FORM SPESIFIKASI

I DATA ADMINISTRASI (*
JENIS PRODUK : Endoscope and accessories
NAMA PRODUK : RICHARD WOLF Percutaneous Universal Nephroscope (PCN)
MODEL/TIPE PRODUK : Terlampir
NO. REGISTRASI DAN MASA BERLAKU : KEMENKES RI AKL 20801013360 / 31 Desember 2022
NAMA SOLE AGENT : PT. SURGIKA ALKESINDO
ALAMAT SOLE AGENT : Jl. Letjen. Suprapto No. 60 Gd. Indra Sentral unit G-H, Cempaka Putih, JakPu
PHONE/ FAX. / E-MAIL : (021) 4253634
NAMA PABRIK : RICHARD WOLF GmbH, GERMANY
RICHARD WOLF GmbH 75438 Knittlingen,Pforzheimerstr. 32 Telephone:
ALAMAT PABRIK : +49 70 43 35-0 Telefax: +49 70 43 35-300, info@richard-wolf.com,
www.richard-wolf.com
* seluruh data izin edar sesuai izin registrasi

Data administrasi diisi sesuai dengan data yang tercantum dalam izin edar

II DATA SPESIFIKASI (*
(*untuk informasi spesifikasi lain yang dimiliki alkes semua dimasukan kedalam
informasi tambahan
INFORMASI PRODUK

COUNTRY OF ORIGIN RICHARD WOLF GmbH, GERMANY

RICHARD WOLF GmbH 75438 Knittlingen,Pforzheimerstr. 32 Telephone:
+49 70 43 35-0 Telefax: +49 70 43 35-300, info@richard-wolf.com,
FACTORY OF ORIGIN www.richard-wolf.com
OUTSOURCE EXTERNAL MANUFACTURE (OEM)
PRODUCT'S REGISTRATION (AKL/AKD)
PRODUCT'S CERTIFICATION
FDA Clearance
CE Mark (MDD)
Certificate ISO 13485
Certificate ....
(* informasi produk di isi sesuai dengan yang dimiliki oleh produk tersebut

Features:

TECHNICAL DATA :

No DESCRIPTION QTY SPECIFICATION

TELESCOPE DILATOR 9-27FR 1 set with 7 pcs, gradation 3Fr, reusable
AMPLATZ SHEATH FOR NEPHROSCOPE 24.3FR 1 round, fixed irrigation tap, distal end straight, reusable
RIGID GRASP. FORCEPS 10.5FR WL 340MM 1 double action, non-dismantling, reusable
RIGID GRASP. FORCEPS 10.5FR WL 365MM 1 three-armed, take-apart, reusable
SHEATH FOR NEPHROSCOPE 24FR 1 round, rotatable stopcock, distal end straight, quick-lock, reusable
OBTURATOR FOR NEPHROSCOPE 24FR 1 round, cannulated, rounded distal end, reusable
rigid, with parallel ocular lens, working channel for instruments up to
NEPHROSCOPE 20° 24FR WL 224MM 1
10.5Fr, rod lens system
GRASPING FORCEPS BNDL 1 Grasping forceps
STERI CONTAINER W 200MM L 400MM H 60MM 6 Steri container with cover and peg mats
rigid, with lateral ocular lens, working channel for instruments up to 6Fr,
NEPHROSCOPE 12° 12FR WL 225MM 1
rod lens system
SHEATH FOR NEPHROSCOPE 18FR 1 round, rotatable stopcock, distal end straight, quick-lock, reusable
OBTURATOR FOR NEPHROSCOPE 18FR 1 round, cannulated, rounded distal end, reusable
SHEATH FOR NEPHROSCOPE 15FR 1 round, rotatable stopcock, distal end straight, quick-lock, reusable
OBTURATOR FOR NEPHROSCOPE 15FR 1 round, cannulated, rounded distal end, reusable
SHEATH FOR NEPHROSCOPE 18FR 1 round, rotatable stopcock, distal end straight, quick-lock, reusable
DILATOR 12FR 1 for "One-Step" - Bougie application, cannulated, reusable
DILATOR 15FR 1 for "One-Step" - Bougie application, cannulated, reusable
RIGID GRASP. FORCEPS 6FR WL 365MM 2 mouse tooth, double action, non-dismantling, reusable
RIGID GRASP. FORCEPS 6FR WL 365MM 2 mouse tooth, double action, non-dismantling, reusable
GRASPING FORCEPS BNDL 2 Grasping forceps