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Tsi Cs-0053

by Tedan Surgical Innovations, L.L.C.

Tsi Cs-0053 is a Class I device made by Tedan Surgical Innovations, L.L.C., listed in FDA GUDID since 8 Aug 2017 (UDI-DI 00843059105315), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00843059105315 UDI-DI Date8 Aug 2017ListedStatusListed 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  • Withdrawn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
Tsi
Generic name
Surgical retractor/retraction system blade, reusable
Model / reference
CS-0053
Primary DI / UDI-DI
00843059105315
FDA product code
MDM
GMDN term
Surgical retractor/retraction system blade, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)