Identity
- Trade Name
- Super View® Pack, Pivot Plus (40101+40227) FDA UDI
- Generic Name
- Ophthalmic diagnostic condensing lens FDA UDI
- Device Name
- 1 Each SUPER VIEW® Pack, Pivot Plus & 1 Each 40101 Microscope Head Cover Drape FDA UDI
- Model / Reference
- 40229 FDA UDI
- Description
- 1 Each SUPER VIEW® Pack, Pivot Plus & 1 Each 40101 Microscope Head Cover Drape FDA UDI
Identifiers
- Catalog Number
- 40229 FDA UDI
- Primary DI / UDI-DI
- 00852475007080 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- Ophthalmic diagnostic condensing lens FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
No
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 diagnostic condensing lens
Super View® Pack, Pivot Plus (40101+40227) by Oculus Surgical 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
- Oculus Surgical Inc
Sources (1)
- FDA UDI 0946f9c8-d5ab-4d94-96ca-083745cac348 36 fields · synced May 30, 2026