Identity
- Trade Name
- Silicone Penrose Drain Tube FDA UDI
- Generic Name
- Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
- Model / Reference
- 2010-5425 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 34711182604883 FDA UDI
- FDA Product Code
- GCD FDA UDI
- GMDN Term
- Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical capillary wound drain, luminal, synthetic polymer
Silicone Penrose Drain Tube by Fortune Medical Instrument Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical capillary wound drain, luminal, synthetic polymer.
- TAUT — TELEFLEX INCORPORATED · Class II
- Silicone Tubing, Translucent — Bentec Medical OpCo, LLC. · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Silicone Tubing, Penrose Drain — Bentec Medical OpCo, LLC. · Class I
- Axiom® — AXIOM MEDICAL, INCORPORATED · Class II
- Malecot — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class I
- Silicone Tubing, Radiopaque — Bentec Medical OpCo, LLC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
Sources (1)
- FDA UDI 48423ffa-5c23-4f46-be60-42c34e162f5c 32 fields · synced Jun 1, 2026