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BioStamp® BRCA02

by MC10, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 NumberB493BRCA02 UDI-DI Date31 Aug 2018ListedStatusListed GUDID: not 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  • Withdrawn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
BioStamp®
Generic Name
Biomechanical function analysis/rehabilitation software
Model / Reference
BRCA02
Primary DI / UDI-DI
B493BRCA02
FDA Product Code
MWI, LEL, IKN, DRG
GMDN Term
Biomechanical function analysis/rehabilitation software
Device Class
Class II
Regulation Number
870.2300, 882.5050, 890.1375, 870.2910
GUDID distribution status
Not in Commercial Distribution

Other devices from MC10, Inc.

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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