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Bard® X-Force® Nephrostomy Balloon Dilation Catheter
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- Bard® X-Force® Nephrostomy Balloon Dilation Catheter FDA UDI
- Generic Name
- Nephrostomy catheter FDA UDI
- Device Name
- Bard® X-Force® Nephrostomy Balloon Dilation Catheter FDA UDI
- Model / Reference
- 995081 FDA UDI
- Description
- Bard® X-Force® Nephrostomy Balloon Dilation Catheter FDA UDI
Identifiers
- Catalog Number
- 995081 FDA UDI
- Primary DI / UDI-DI
- 00801741080715 FDA UDI
- FDA Product Code
- LJE FDA UDI
- GMDN Term
- Nephrostomy catheter FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 15 Centimeter FDA UDIOuter Diameter — 8 Millimeter FDA UDIBalloon Length — 15 Centimeter FDA UDI
Category: Nephrostomy catheter
Bard® X-Force® Nephrostomy Balloon Dilation Catheter by C. R. Bard, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nephrostomy catheter.
- Nephro-Cath Nephrostomy Drainage Catheter — Uresil Corp. · Class I
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- Nephro-Cath Nephrostomy Drainage Catheter — Uresil Corp. · Class I
- Malecot — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- Kolibri — Coloplast A/S · U
- Total Abscession — ANGIODYNAMICS, INC · Class I
- Percuflex™ — Boston Scientific · 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 U | Pending data |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
Sources (1)
- FDA UDI cb64d15c-b5b1-4f5e-8b41-999d71880d02 37 fields · synced May 31, 2026