Irrigation/suction gravity system w/o cannula

GUDID E296OMSFLA02GESC1

AB MEDICA

Laparoscopic irrigation/aspiration cannula
Primary Device IDE296OMSFLA02GESC1
NIH Device Record Key22981065-7b68-4ab3-8880-8d82cd2c2510
Commercial Distribution StatusIn Commercial Distribution
Brand NameIrrigation/suction gravity system w/o cannula
Version Model NumberOMS/FLA02-GE-SC
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
HIBCCE296OMSFLA02GESC0 [Unit of Use]
HIBCCE296OMSFLA02GESC1 [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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