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Aztron Suture Loop

FDA UDI

Class II (US FDA UDI)

by Threadstone LLC

Identity

Trade Name
Aztron Suture Loop FDA UDI
Generic Name
Polyolefin/fluoropolymer suture, multifilament FDA UDI
Device Name
1.2mm White/Black Polyblend Surgical Suture Tape Shuttle Loop, 2" Loop FDA UDI
Model / Reference
ST-01-L FDA UDI
Description
1.2mm White/Black Polyblend Surgical Suture Tape Shuttle Loop, 2" Loop FDA UDI

Identifiers

Primary DI / UDI-DI
00810129094275 FDA UDI
FDA Product Code
GAT FDA UDI
GMDN Term
Polyolefin/fluoropolymer suture, multifilament FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Polyolefin/fluoropolymer suture, multifilament

Aztron Suture Loop by Threadstone LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyolefin/fluoropolymer suture, multifilament.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Threadstone LLC

Sources (1)

  • FDA UDI 421b8c77-051a-421b-97f3-67909a3e8f9d 33 fields · synced May 30, 2026