Identity
- Trade Name
- CustomEyes® FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- CUSTOMEYES KIT 58001070 (1/EA) FDA UDI
- Model / Reference
- 58001070 FDA UDI
- Description
- CUSTOMEYES KIT 58001070 (1/EA) FDA UDI
Identifiers
- Catalog Number
- 58001070 FDA UDI
- Primary DI / UDI-DI
- 30886158022139 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
A comprehensive medical device directory listing the CustomEyes Kit, a single-use ophthalmic surgical procedure kit that contains various surgical instruments and materials for an ophthalmic surgical procedure. The device is not exclusively dedicated to implantation tools or pharmaceuticals and does not contain any MRIs.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Beaver-Visitec International, Inc.
Sources (1)
- FDA UDI aff98263-e0a3-4c17-b7ef-56280c31fa19 36 fields · synced Jul 24, 2026