Identity
- Trade Name
- Novo Surgical Inc. FDA UDI
- Generic Name
- Surgical fluid/gas irrigator FDA UDI
- Device Name
- nichamin hydrodissection cannula, 25 gauge, curved cannula design, flattened tip, 33mm overall length FDA UDI
- Model / Reference
- NSE4421H-1 FDA UDI
- Description
- nichamin hydrodissection cannula, 25 gauge, curved cannula design, flattened tip, 33mm overall length FDA UDI
Identifiers
- Catalog Number
- NSE4421H-1 FDA UDI
- Primary DI / UDI-DI
- 00842331189203 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Surgical fluid/gas irrigator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical fluid/gas irrigator
Novo Surgical Inc. by Novo Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical fluid/gas irrigator.
- UNBRANDED — Advance Medical Designs, Inc. · Class II
- UNBRANDED — Advance Medical Designs, Inc. · Class II
- UNBRANDED — Advance Medical Designs, Inc. · Class II
- IRRIGATOR/INSUFFLATOR — PENTAX of America, Inc. · Class II
- UNBRANDED — Advance Medical Designs, Inc. · Class II
- Closed Fluid System — Advance Medical Designs, Inc. · Class II
- UNBRANDED — Advance Medical Designs, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Novo Surgical, Inc.
Sources (1)
- FDA UDI c9e3fe62-ec7d-4ea5-aa00-8632bae5f379 35 fields · synced May 31, 2026