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Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet FDA UDI
- Generic Name
- Suprapubic needle, single-use FDA UDI
- Device Name
- Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet for use with Bard® Nephrostomy Short Tip Councill Catheters FDA UDI
- Model / Reference
- 190500 FDA UDI
- Description
- Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet for use with Bard® Nephrostomy Short Tip Councill Catheters FDA UDI
Identifiers
- Catalog Number
- 190500 FDA UDI
- Primary DI / UDI-DI
- 00801741030383 FDA UDI
- FDA Product Code
- KOD FDA UDI
- GMDN Term
- Suprapubic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 6 French FDA UDI
Category: Suprapubic needle, single-use
Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
Sources (1)
- FDA UDI 920515d3-2f60-4b12-8fc6-6264606de51d 36 fields · synced May 29, 2026