Identity
- Trade Name
- NOVADAQ and PINPOINT FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- Pinpoint Laparoscope - 5mm, Standard, 0 with Wolf and Storz adaptor FDA UDI
- Model / Reference
- SC9504 FDA UDI
- Description
- Pinpoint Laparoscope - 5mm, Standard, 0 with Wolf and Storz adaptor FDA UDI
Identifiers
- Catalog Number
- SC9504 FDA UDI
- Primary DI / UDI-DI
- 00858701006124 FDA UDI
- FDA Product Code
- IZI FDA UDIGCJ FDA UDI
- GMDN Term
- Rigid optical laparoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1600 FDA UDI876.1500 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
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical laparoscope
NOVADAQ and PINPOINT by Novadaq Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical laparoscope.
- Laparoscope — SOPRO-COMEG GmbH · Class II
- ELMED — ELMED INCORPORATED · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- MEDIVISION — MEDIVISION, INC. · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- CONMED — Conmed Corporation · Class II
- ELMED — ELMED INCORPORATED · Class II
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 fdf5b8ba-4763-4fef-b353-07908e7dbb6b 35 fields · synced May 30, 2026