C35-Rounded Stylus L=330mm D=3,5mm C35-RS-33

GUDID E496C35RS330

AB MEDICA

Laparoscopic surgical procedure kit, non-medicated, reusable
Primary Device IDE496C35RS330
NIH Device Record Keybd3a4faf-e771-43ed-93c5-406983c3b7fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameC35-Rounded Stylus L=330mm D=3,5mm
Version Model NumberC35-RS-33
Catalog NumberC35-RS-33
Company DUNS260445203
Company NameAB MEDICA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE496C35RS330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E496C35RS330]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-11
Device Publish Date2020-03-03

Devices Manufactured by AB MEDICA

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E496COEC350750 - REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=75MM2021-08-02
E496COEC351000 - REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=100MM2021-08-02
E496LILIP2SC20ST0 - Low Impact™ Curved Scissors, Jaw Insert (sterile) L=20cm 2021-06-21
E496C35IP2AL330 - C35-Allis Grasping Forceps, 2 mobile jaws Insert L=33mm D=3,5mm2021-04-09
E496C35IP2BI330 - C35-Biopsy 2 mobile jaws insert L 33cm D 3,5mm2021-04-09

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