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American Medicals 1

by American Medicals GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB356ED107160 UDI-DIDate3 Dec 2025ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
American Medicals
Generic Name
Orthopaedic joint/limb rongeur
Model / Reference
1
Primary DI / UDI-DI
B356ED107160
FDA Product Code
EMH
GMDN Term
Orthopaedic joint/limb rongeur
Device Class
Class I
Regulation Number
872.4565
Commercial Distribution
In Commercial Distribution
Sterilization Method
Microwave Radiation

Other devices from American Medicals

See all devices from American Medicals →

Properties

  • Premarket Exempt

Other properties (13)

  • 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
  • Manufacturing Date: No