SaddleLoop 18g x 10cm with Blunt Needle

GUDID 20634624015412

QUEST MEDICAL INC

Surgical support tape, non-bioabsorbable
Primary Device ID20634624015412
NIH Device Record Key8764567f-4ca4-42d9-915f-f412888c2a55
Commercial Distribution StatusIn Commercial Distribution
Brand NameSaddleLoop 18g x 10cm with Blunt Needle
Version Model Number1541
Company DUNS041810693
Company NameQUEST MEDICAL INC
Device Count20
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
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
GS100634624015418 [Unit of Use]
GS120634624015412 [Primary]

FDA Product Code

GAESnare, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-13
Device Publish Date2019-10-10

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