Identity
- Trade Name
- L-Box® FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- Silicone, SST FDA UDI
- Model / Reference
- LB-135 FDA UDI
- Description
- Silicone, SST FDA UDI
Identifiers
- Catalog Number
- LB-135 FDA UDI
- Primary DI / UDI-DI
- M711LB1350 FDA UDI
- 510(k) Number
- K121581 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fibreoptic light cable
L-Box® by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibreoptic light cable.
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- JEDMED — JEDMED Instrument Company · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
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- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- JEDMED — JEDMED Instrument Company · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- FENTEX — FENTEX medical GmbH · Class I
Cleared under the same submission
K121581 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 II | Pending data |
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Manufacturer
- Manufacturer
- Innovasis, Inc.
Sources (1)
- FDA UDI 29b32be7-20cc-40bc-af77-638bd97cf07d 36 fields · synced Jun 1, 2026