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Randolph AF005

by Randolph Engineering GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00044409916227 UDI-DIDate23 Nov 2022ListedStatusIn 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  • Withdrawn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
Randolph
Generic Name
Non-prescription sunglasses
Model / Ref / Catalog
AF005
Primary DI / UDI-DI
00044409916227
FDA Product Code
HQY
GMDN Term
Non-prescription sunglasses
Device Class
Class I
Regulation Number
886.5850
Commercial Distribution
In Commercial Distribution

Related devices

Category: Tinted non-prescription spectacles

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