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HyperSuture TST-184

by Threadstone LLC

HyperSuture TST-184 is a Class II device made by Threadstone LLC, listed in FDA GUDID since 1 Jul 2025 (UDI-DI 00810129094251), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810129094251 UDI-DI Date1 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
HyperSuture
Generic name
Polyolefin/fluoropolymer suture, multifilament
Model / reference
TST-184
Primary DI / UDI-DI
00810129094251
FDA product code
GAT
GMDN term
Polyolefin/fluoropolymer suture, multifilament
Device class
Class II
Regulation number
878.5000
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Polyolefin/fluoropolymer suture, multifilament

Similar devices in this category

Other devices filed under Polyolefin/fluoropolymer suture, multifilament.

Other devices from Threadstone LLC

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)