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Black & Black Surgical, Inc. B64040

by Black & Black Surgical, Inc. United States GUDID

Product code HWM

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840329838683 UDI-DIDate30 Sep 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
Black & Black Surgical, Inc.
Generic Name
Orthopaedic osteotome
Model / Ref / Catalog
B64040
Description
SHEEHAN OSTEOTOME; 6 1/4''(16CM) , 10MM
Primary DI / UDI-DI
00840329838683
FDA Product Code
HWM
GMDN Term
Orthopaedic osteotome
Device Class
Class I
Regulation Number
878.4800
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Black & Black Surgical, Inc.

See all devices from Black & Black Surgical, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
Other properties (11)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 223d4232-ce56-40aa-bf77-f132a5c3655e 35 fields · synced 23 Oct 2026