Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Suction system catheter, general-purpose FDA UDI
- Device Name
- 3 3/4" House Suction, 2.5fr x 4fr, 5 1/2" OL FDA UDI
- Model / Reference
- SD92083014 FDA UDI
- Description
- 3 3/4" House Suction, 2.5fr x 4fr, 5 1/2" OL FDA UDI
Identifiers
- Catalog Number
- SD92083014 FDA UDI
- Primary DI / UDI-DI
- B382SD920830140 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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Also classified as Suction system catheter, general-purpose.
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- Gen2 — SURGIX MEDICAL LLC · Class II
- 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 a91793ce-8db3-46a1-8490-c79f596d6f47 35 fields · synced Jun 8, 2026