HD3 laparoscope, 5.5mm, 0°, autoclavable, HM C05-OPT-0

GUDID E496C05OPT00

AB MEDICA

Rigid optical laparoscope
Primary Device IDE496C05OPT00
NIH Device Record Key3db241ab-fe64-43be-81e0-730256e7ba90
Commercial Distribution StatusIn Commercial Distribution
Brand NameHD3 laparoscope, 5.5mm, 0°, autoclavable, HM
Version Model NumberC05-OPT-0
Catalog NumberC05-OPT-0
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
HIBCCE496C05OPT00 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


[E496C05OPT00]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-13
Device Publish Date2020-08-05

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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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