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De Mayo Universal Distractor® 621AS

by Innovative Medical Products, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00696588008257 UDI-DIDate20 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
De Mayo Universal Distractor®
Generic Name
Orthopaedic surgical distractor, external
Model / Ref / Catalog
621AS
Primary DI / UDI-DI
00696588008257
FDA Product Code
FWZ
GMDN Term
Orthopaedic surgical distractor, external
Device Class
Class I
Regulation Number
878.4950
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Innovative Medical Products, Inc.

See all devices from Innovative Medical Products, Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Serial Number: No
  • Expiration Date: No