Identity
- Trade Name
- BONASSE FDA UDI
- Generic Name
- Contact lens case FDA UDI
- Model / Reference
- SC-128 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872850168 FDA UDI
- 510(k) Number
- K991206 FDA UDI
- FDA Product Code
- LRX FDA UDI
- GMDN Term
- Contact lens case FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5928 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Contact lens case
Bonasse by Bonasse Enterprises Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K991206 also covers:
- BAUSH & LOMB — BONASSE ENTERPRISES CO., LTD.
- BONASSE — BONASSE ENTERPRISES CO., LTD.
- BONASSE — BONASSE ENTERPRISES CO., LTD.
- BONASSE — BONASSE ENTERPRISES CO., LTD.
- BONASSE — BONASSE ENTERPRISES CO., LTD.
- BONASSE — BONASSE ENTERPRISES CO., LTD.
- BONASSE — BONASSE ENTERPRISES CO., LTD.
- BONASSE — BONASSE ENTERPRISES CO., LTD.
- BONASSE — BONASSE ENTERPRISES CO., LTD.
- BONASSE — BONASSE ENTERPRISES CO., LTD.
- BONASSE — BONASSE ENTERPRISES CO., LTD.
- VOGUESTRAP — BONASSE ENTERPRISES CO., LTD.
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
- Bonasse Enterprises Co., Ltd.
Sources (1)
- FDA UDI 6b3d0f99-373f-41c9-9824-d53aa4461de2 33 fields · synced May 30, 2026