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Coronary Bypass Marker Rev1

by First Call, 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 NumberB776106961 UDI-DIDate3 Oct 2019ListedStatusListed 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  • Withdrawn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
Coronary Bypass Marker
Generic Name
Metallic coronary bypass marker
Model / Ref / Catalog
Rev1, 10-696
Primary DI / UDI-DI
B776106961
510(k) Number
FDA Product Code
MAB
GMDN Term
Metallic coronary bypass marker
Device Class
Class II
Regulation Number
870.3450
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Related devices

Category: Metallic coronary bypass marker

Other devices from First Call, Inc.

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number

Other properties (10)

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