Identity
- Trade Name
- Orbit Subretinal Delivery System FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Tubing Set FDA UDI
- Model / Reference
- PN1008919-001 FDA UDI
- Description
- Tubing Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850009362018 FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Orbit Subretinal Delivery System by Gyroscope Usa, Inc. — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Gyroscope Usa, Inc.
Sources (1)
- FDA UDI 17a51806-06c1-4ad4-bcab-112e7e1c8d02 33 fields · synced May 30, 2026