Identity
- Trade Name
- Pro-Paks FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Ophthalmic pack. PRO-PAKS Personalized Eye Tray Systems offer the best option for Surgical Packs and a Systematized approach combined with the Personal Touch. PRO-PAKS personalized procedure trays offers a fully custom pack, from EXACT components to EXACT quantities and the ability to adapt the sequence of which the individual items are placed in the pack. FDA UDI
- Model / Reference
- 21410F FDA UDI
- Description
- Ophthalmic pack. PRO-PAKS Personalized Eye Tray Systems offer the best option for Surgical Packs and a Systematized approach combined with the Personal Touch. PRO-PAKS personalized procedure trays offers a fully custom pack, from EXACT components to EXACT quantities and the ability to adapt the sequence of which the individual items are placed in the pack. FDA UDI
Identifiers
- Catalog Number
- 21410F FDA UDI
- Primary DI / UDI-DI
- 10810003223804 FDA UDI
- FDA Product Code
- OJK FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4790 FDA UDI
- 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Pro-Paks by Microspecialities, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Microspecialities, Inc.
Sources (1)
- FDA UDI 9f1859ff-7b47-422e-909f-26278fcce17f 35 fields · synced May 30, 2026