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Skullerz SAGA-AFAS

by Ergodyne GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00720476591351 UDI-DIDate29 Aug 2023ListedStatusListed 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  • Withdrawn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
Skullerz
Generic Name
Non-prescription sunglasses
Model / Ref / Catalog
SAGA-AFAS, 59135
Primary DI / UDI-DI
00720476591351
FDA Product Code
HQY
GMDN Term
Non-prescription sunglasses
Device Class
Class I
Regulation Number
886.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tinted non-prescription spectacles

Other devices from Ergodyne

See all devices from Ergodyne →

Properties

  • Premarket Exempt
  • Manufacturing Date

Other properties (12)

  • 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