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StrongArm Surgical Holders and Positioners 21281

by Flexbar Machine Corp.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842102116384 UDI-DI Date26 Nov 2025ListedStatusListed 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  • Withdrawn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
StrongArm Surgical Holders and Positioners
Generic Name
Surgical instrument assist arm system, manually-adjusted
Model / Reference
21281
Primary DI / UDI-DI
00842102116384
FDA Product Code
BWN
GMDN Term
Surgical instrument assist arm system, manually-adjusted
Device Class
Class I
Regulation Number
878.4950
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Flexbar Machine Corp.

See all devices from Flexbar Machine Corp. →

Properties

  • Premarket Exempt
  • Manufacturing Date

Other properties (12)

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