Identity
- Trade Name
- Silicone Round Drain FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- Silicone Round Drain, Medium-Large 3/16" (15 Fr., 4.7mm) O.D., 49" (124.4cm) Long, 10" (25.4cm) Hole Pattern, X-Ray Opaque Stripe FDA UDI
- Model / Reference
- 0070220 FDA UDI
- Description
- Silicone Round Drain, Medium-Large 3/16" (15 Fr., 4.7mm) O.D., 49" (124.4cm) Long, 10" (25.4cm) Hole Pattern, X-Ray Opaque Stripe FDA UDI
Identifiers
- Catalog Number
- 0070220 FDA UDI
- Primary DI / UDI-DI
- 00801741049446 FDA UDI
- FDA Product Code
- GBX FDA UDI
- GMDN Term
- Closed-wound drain, non-bioabsorbable 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 15 French FDA UDI
Category: Closed-wound drain, non-bioabsorbable
Silicone Round Drain by C. R. Bard, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Closed-wound drain, non-bioabsorbable.
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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
- C. R. Bard, Inc.
Sources (1)
- FDA UDI b4f9df65-6dfd-4284-8c49-65d569749ee6 36 fields · synced May 31, 2026