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Original Penguin STIPBK53

by Kenmark Optical Co., Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00715317096966 UDI-DIDate12 Aug 2021ListedStatusListed 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  • Withdrawn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
Original Penguin
Generic Name
Prescription spectacles
Model / Reference
STIPBK53
Primary DI / UDI-DI
00715317096966
FDA Product Code
HQZ
GMDN Term
Prescription spectacles
Device Class
Class I
Regulation Number
886.5842
GUDID distribution status
In Commercial Distribution

Related devices

Category: Prescription spectacles

Other devices from Kenmark Optical Co., Inc.

See all devices from Kenmark Optical Co., Inc. →

Properties

  • Over-the-Counter
  • Premarket Exempt

Other properties (12)

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