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Freehand Ring FR403

by Pura Dental Products LLC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860000626903 UDI-DI Date17 Dec 2020ListedStatusListed 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  • Withdrawn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
Freehand Ring
Generic Name
Wearable dental procedure holding ring
Model / Reference
FR403
Primary DI / UDI-DI
00860000626903
FDA Product Code
EJB
GMDN Term
Wearable dental procedure holding ring
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Wearable dental procedure holding ring cleaning padWearable dental procedure holding ringWearable dental procedure holding ring well

Properties

  • Combination Product
  • Premarket Exempt

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No