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BMAN Access Diamond Needle AAN-09-BMACS

by Surgentec LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00810131884352 UDI-DI Date9 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BMAN Access Diamond Needle
Generic Name
Bone access cannula
Model / Reference
AAN-09-BMACS
Primary DI / UDI-DI
00810131884352
510(k) Number
FDA Product Code
PDQ
GMDN Term
Bone access cannula
Device Class
Class II
Regulation Number
874.1820
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243945)

Show all (12)

Other devices from Surgentec LLC

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No