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Bioarch SW1108

by Wright Medical Technology, Inc.

Bioarch SW1108 is a Class I device made by Wright Medical Technology, Inc., listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00889797055482), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889797055482 UDI-DI Date17 Sep 2016ListedStatusListed 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  • Withdrawn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
Bioarch
Generic name
Orthopaedic implant calibration pin
Model / Ref / Catalog
SW1108
Primary DI / UDI-DI
00889797055482
FDA product code
LXH
GMDN term
Orthopaedic implant calibration pin
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant calibration pin

Similar devices in this category

Other devices filed under Orthopaedic implant calibration pin.

Other devices from Wright Medical Technology, Inc.

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Properties

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