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Level One 01-022-01-07

by KLS-Martin L.P.

Level One 01-022-01-07 is a Class I device made by KLS-Martin L.P., listed in FDA GUDID since 26 Sep 2018 (UDI-DI 00888118004260), registry data as of 2 Nov 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 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888118004260 UDI-DI Date26 Sep 2018ListedStatusListed 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  • Withdrawn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
Level One
Generic name
Fluted surgical drill bit, single-use
Model / reference
01-022-01-07
Primary DI / UDI-DI
00888118004260
FDA product code
HTW
GMDN term
Fluted surgical drill bit, single-use
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (10, all answered No)