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Target Endoscopic Instrument TML0001

by SOLENDOS Inc.

Target Endoscopic Instrument TML0001 is a Class I device made by SOLENDOS Inc., listed in FDA GUDID since 9 Dec 2024 (UDI-DI 08800147700823), 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 Number08800147700823 UDI-DI Date9 Dec 2024ListedStatusListed 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  • Withdrawn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
Target Endoscopic Instrument
Generic name
Surgical mallet
Model / reference
TML0001
Primary DI / UDI-DI
08800147700823
FDA product code
HXL
GMDN term
Surgical mallet
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical mallet

Other devices from SOLENDOS Inc.

See all devices from SOLENDOS Inc. →

Properties

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