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Lexer Osteotome 330-0091

by Sontec Instruments, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00192896105935 UDI-DI Date7 Dec 2020ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Lexer Osteotome
Generic Name
Orthopaedic osteotome
Model / Reference
330-0091
Primary DI / UDI-DI
00192896105935
FDA Product Code
HWM
GMDN Term
Orthopaedic osteotome
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
Size
Length — 8.75 Inch

Related devices

Category: Orthopaedic osteotome

Other devices from Sontec Instruments, Inc.

See all devices from Sontec Instruments, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No