Identity
- Trade Name
- InnoVoyce Laser Fiber FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Device Name
- InnoVoyce Laser Fiber .300 1 Pack RFID FDA UDI
- Model / Reference
- B FDA UDI
- Description
- InnoVoyce Laser Fiber .300 1 Pack RFID FDA UDI
Identifiers
- Catalog Number
- I0128-ASY-300063-300 FDA UDI
- Primary DI / UDI-DI
- 00860011812128 FDA UDI
- 510(k) Number
- K220793 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General/multiple surgical laser system beam guide, single-use
InnoVoyce Laser Fiber by InnoVoyce LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- InnoVoyce LLC
Sources (1)
- FDA UDI 48898808-f4f3-49df-a8de-db0c1e2850af 36 fields · synced May 30, 2026