Skip to content

Sil-Ophtho 1

by Sil-Ophtho, LLC 4 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 NumberG601100T0 UDI-DI Date14 Mar 2024ListedStatusListed 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  • Withdrawn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
Sil-Ophtho
Generic Name
Eyeball prosthesis lubricant
Model / Ref / Catalog
1, 100T
Primary DI / UDI-DI
G601100T0
FDA Product Code
HQH
GMDN Term
Eyeball prosthesis lubricant
Device Class
Class I
Regulation Number
886.3200
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 6 Milliliter

Related devices

Category: Eyeball prosthesis lubricant

Similar devices

Also classified as Eyeball prosthesis lubricant.

Other devices from Sil-Ophtho, LLC

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