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Blue Elephant MIA black

by Blue Elephant Inc GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800348922734 UDI-DIDate6 Aug 2026ListedStatusListed 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  • Withdrawn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 23 Oct 2026.

Specification

GUDID

Trade Name
Blue Elephant
Generic Name
Spectacle frame
Model / Reference
MIA black
Primary DI / UDI-DI
08800348922734
FDA Product Code
HQZ
GMDN Term
Spectacle frame
Device Class
Class I
Regulation Number
886.5842
GUDID distribution status
In Commercial Distribution

Other devices from Blue Elephant Inc

See all devices from Blue Elephant Inc →

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