Disposable valve for trocar D=3,5mm (x3) C35-SEAL-3

GUDID E496C35SEAL30

AB MEDICA

Laparoscopic access cannula seal, single-use
Primary Device IDE496C35SEAL30
NIH Device Record Keya4a72da3-7d7f-4a4d-8b08-00b6549fd6a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable valve for trocar D=3,5mm (x3)
Version Model NumberC35-SEAL-3
Catalog NumberC35-SEAL-3
Company DUNS260445203
Company NameAB MEDICA
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE496C35SEAL30 [Unit of Use]
HIBCCE496C35SEAL31 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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

E496C35HH330 - C35-Hand Activated HOOK L=330mm2021-08-02
E496COEC3501200 - REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=120MM2021-08-02
E496COEC350600 - REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=60MM2021-08-02
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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