PTFE coated cannula Ø 10 mm, 330 mm for irrigation/suction system, single use

GUDID E296OMSFLA031

AB MEDICA

Laparoscopic irrigation/aspiration cannula
Primary Device IDE296OMSFLA031
NIH Device Record Key5815bf9e-b6c1-4a97-a9c1-ce17a96c6b56
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTFE coated cannula Ø 10 mm, 330 mm for irrigation/suction system, single use
Version Model NumberOMS/FLA03
Company DUNS260445203
Company NameAB MEDICA
Device Count4
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
HIBCCE296OMSFLA030 [Unit of Use]
HIBCCE296OMSFLA031 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-12-10
Device Publish Date2018-07-23

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