Identity
- Trade Name
- Synergetics FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- I-PACK Injection Kit Custom FDA UDI
- Model / Reference
- 18063 FDA UDI
- Description
- I-PACK Injection Kit Custom FDA UDI
Identifiers
- Catalog Number
- 18063 FDA UDI
- Primary DI / UDI-DI
- 10841305101088 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Synergetics by Synergetics Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Synergetics Usa, Inc.
Sources (1)
- FDA UDI a0575556-7f44-4117-a009-0bb2db68ca8e 36 fields · synced May 30, 2026