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Sontec-Michele Trephine 419-393

by Sontec Instruments, Inc.

Sontec-Michele Trephine 419-393 is a Class I device made by Sontec Instruments, Inc., listed in FDA GUDID since 11 Sep 2018 (UDI-DI 00192896038127), 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 Number00192896038127 UDI-DI Date11 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  • Withdrawn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
Sontec-Michele Trephine
Generic name
Bone trephine, reusable
Model / Ref / Catalog
419-393
Primary DI / UDI-DI
00192896038127
FDA product code
HWK
GMDN term
Bone trephine, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Size
Length — 6.25 Inch

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Properties

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