Identity
- Trade Name
- PINPOINT FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- Light Guide Cable FDA UDI
- Model / Reference
- PC9004 FDA UDI
- Description
- Light Guide Cable FDA UDI
Identifiers
- Catalog Number
- PC9004 FDA UDI
- Primary DI / UDI-DI
- 00858701006568 FDA UDI
- 510(k) Number
- K150956 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Category: Fibreoptic light cable
Pinpoint by Novadaq Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibreoptic light cable.
- JEDMED — JEDMED Instrument Company · Class I
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- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Gimmi — Gimmi GmbH · Class II
- 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
K150956 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
- Novadaq Technologies Inc
Sources (1)
- FDA UDI e7570d4c-dabe-4f01-b331-4cbba2aefca2 36 fields · synced May 30, 2026