Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Suction system catheter, general-purpose FDA UDI
- Device Name
- 9fr 12.5cm Frazier Suction Tube with Finger Valve, Stylet and Fiber Optic Channel FDA UDI
- Model / Reference
- SD61042-09F FDA UDI
- Description
- 9fr 12.5cm Frazier Suction Tube with Finger Valve, Stylet and Fiber Optic Channel FDA UDI
Identifiers
- Catalog Number
- SD61042-09F FDA UDI
- Primary DI / UDI-DI
- B382SD6104209F0 FDA UDI
- FDA Product Code
- KCB FDA UDI
- GMDN Term
- Suction system catheter, general-purpose FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
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: Suction system catheter, general-purpose
Surgical Direct by Surgical Direct, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI aabc0e7d-506a-445a-9fb4-54c1b943f23a 35 fields · synced Jun 6, 2026