Aztron Suture Loop

GUDID 00810129094275

1.2mm White/Black Polyblend Surgical Suture Tape Shuttle Loop, 2" Loop

Threadstone LLC

Polyolefin/fluoropolymer suture, multifilament
Primary Device ID00810129094275
NIH Device Record Key421b8c77-051a-421b-97f3-67909a3e8f9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAztron Suture Loop
Version Model NumberST-01-L
Company DUNS104319989
Company NameThreadstone LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100810129094275 [Primary]

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-09
Device Publish Date2025-07-01

On-Brand Devices [Aztron Suture Loop]

00810129094305USP #2 White/Black Polyblend Surgical Suture Cable Shuttle Loop, 2" Loop
008101290942751.2mm White/Black Polyblend Surgical Suture Tape Shuttle Loop, 2" Loop

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