Identity
- Trade Name
- UNFOLDER SILVER FDA UDI
- Generic Name
- Intraocular lens-insertion cartridge FDA UDI
- Device Name
- SILVER CARTRIDGE THERMOFORMED TR, 30 BX FDA UDI
- Model / Reference
- PSCST30 FDA UDI
- Description
- SILVER CARTRIDGE THERMOFORMED TR, 30 BX FDA UDI
Identifiers
- Catalog Number
- PSCST30 FDA UDI
- Primary DI / UDI-DI
- 05050474530034 FDA UDI
- 510(k) Number
- K961242 FDA UDI
- FDA Product Code
- KYB FDA UDI
- GMDN Term
- Intraocular lens-insertion cartridge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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: Intraocular lens-insertion cartridge
Unfolder Silver by Johnson & Johnson Surgical Vision, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K961242 also covers:
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
- Johnson & Johnson Surgical Vision, Inc.
Sources (1)
- FDA UDI 269c3e83-f4dd-46e4-968b-47efe00a3b3c 37 fields · synced Jun 9, 2026