Identity
- Trade Name
- Orbital Implant Sizer Kit FDA UDI
- Generic Name
- Orbital sphere implant sizer FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 14170 FDA UDI
- Primary DI / UDI-DI
- B091141700 FDA UDI
- FDA Product Code
- FTY FDA UDI
- GMDN Term
- Orbital sphere implant sizer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Ethylene Oxide FDA UDI
Category: Orbital sphere implant sizer
Orbital Implant Sizer Kit by Gulden Ophthalmics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orbital sphere implant sizer.
- Enucleation/Evisceration Sizer — Oculo-Plastik Inc · Class I
- Enucleation/Evisceration Sizer — Oculo-Plastik Inc · Class I
- Enucleation/Evisceration Sizer — Oculo-Plastik Inc · Class I
- Enucleation/Evisceration Sizer — Oculo-Plastik Inc · Class I
- Enucleation/Evisceration Sizer — Oculo-Plastik Inc · Class I
- Enucleation/Evisceration Sizer — Oculo-Plastik Inc · Class I
- Enucleation/Evisceration Sizers (set) — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gulden Ophthalmics
Sources (1)
- FDA UDI 73aa4750-8621-497f-9196-e4de79f8cdb9 33 fields · synced Jun 8, 2026