Identity
- Trade Name
- NOVADAQ®and PINPOINT® FDA UDI
- Generic Name
- Gastrointestinal endoscopic insufflator FDA UDI
- Model / Reference
- PC9061 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858701006162 FDA UDI
- FDA Product Code
- OSX FDA UDIHIF FDA UDIFCX FDA UDI
- GMDN Term
- Gastrointestinal endoscopic insufflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1117 FDA UDI884.1730 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
No
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: Gastrointestinal endoscopic insufflator
NOVADAQ®and PINPOINT® by Novadaq Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal endoscopic insufflator.
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- Protocol Colon Insufflator — Bracco Diagnostics Inc. · Class II
- Erbe ECO2 plus — PALLIARE INC · Class II
- ENDO STRATUS CO2 Insufflator — MEDIVATORS INC. · Class II
- IRRIGATOR/INSUFFLATOR — PENTAX of America, Inc. · 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 c8a813a2-1cab-47d6-9715-7dd8015ad036 32 fields · synced May 30, 2026