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Royal Tek Rt-Ds-10PK-5PK

by Surgical Design, Inc.

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 Number00810055257843 UDI-DI Date17 May 2026ListedStatusListed 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  • Withdrawn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
Royal Tek
Generic Name
Otoscope, direct
Model / Reference
RT-DS-10PK-5PK
Primary DI / UDI-DI
00810055257843
FDA Product Code
HNC
GMDN Term
Otoscope, direct
Device Class
Class I
Regulation Number
886.4350
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No