Identity
- Trade Name
- Orbital sphere implant introducer FDA UDI
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, probe-like, reusable FDA UDI
- Device Name
- A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device. FDA UDI
- Model / Reference
- SPHERE INTRODUCER FDA UDI
- Description
- A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- S6.3050u FDA UDI
- Primary DI / UDI-DI
- 03760087126297 FDA UDI
- FDA Product Code
- HNR FDA UDI
- GMDN Term
- Ophthalmic soft-tissue manipulation forceps, probe-like, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic soft-tissue manipulation forceps, probe-like, reusable
Orbital sphere implant introducer by Fci S A S Fci 20 22 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Fci S A S Fci 20 22
Sources (1)
- FDA UDI ad12ea6b-edfe-4f97-bb3d-5e1afdbf6d44 35 fields · synced Jun 8, 2026