Identity
- Trade Name
- Silicone Suction Cup (10pk) FDA UDI
- Generic Name
- Corneal shield applicator FDA UDI
- Model / Reference
- 2 FDA UDI
Identifiers
- Catalog Number
- 23012 FDA UDI
- Primary DI / UDI-DI
- B091230122 FDA UDI
- FDA Product Code
- KYE FDA UDI
- GMDN Term
- Corneal shield applicator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Corneal shield applicator
Silicone Suction Cup (10pk) by Gulden Ophthalmics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Corneal shield applicator.
- Laser kit — Oculo-Plastik Inc · Class I
- Hayden Medical — Hayden Medical Inc · Class I
- Latex-free Rubber Suction Cups (100 units) — Oculo-Plastik Inc · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Suction Cups (12 units) — Oculo-Plastik Inc · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gulden Ophthalmics
Sources (1)
- FDA UDI 7f50614d-c946-4d39-9c6f-4681124d1b5e 33 fields · synced Jun 8, 2026