Identity
- Trade Name
- Bard® Renal Sheath FDA UDI
- Generic Name
- Nephrostomy catheter FDA UDI
- Device Name
- Bard® Renal Sheath FDA UDI
- Model / Reference
- 992081 FDA UDI
- Description
- Bard® Renal Sheath FDA UDI
Identifiers
- Catalog Number
- 992081 FDA UDI
- Primary DI / UDI-DI
- 00801741095023 FDA UDI
- 510(k) Number
- K080944 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
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 17 Centimeter FDA UDICatheter Gauge — 24 French FDA UDI
Category: Nephrostomy catheter
Bard® Renal Sheath 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
- Flexima™ — Boston Scientific · Class I
- 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
Cleared under the same submission
K080944 also covers:
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 29f1817f-9990-4619-adfd-0bc2a1329610 38 fields · synced May 30, 2026