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Soper Brothers Custom 1

by Soper Brothers, Incorporated 2 variants

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberSHELLV2627 UDI-DI Date3 Mar 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  • Withdrawn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
Soper Brothers Custom
Generic Name
Eyeball prosthesis, custom-made
Model / Reference
1
Primary DI / UDI-DI
SHELLV2627
FDA Product Code
HQH
GMDN Term
Eyeball prosthesis, custom-made
Device Class
Class I
Regulation Number
886.3200
GUDID distribution status
In Commercial Distribution

Other devices from Soper Brothers, Incorporated

Properties

  • Single Use
  • Premarket Exempt
  • Manufacturing Date

Other properties (11)

  • Sterile: 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