Identity
- Trade Name
- Kumar Catheter® FDA UDI
- Generic Name
- Laparoscopic cholangiography injection catheter/needle FDA UDI
- Device Name
- The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholangiography. It comprises a translucent tubing ( 76 cm. length and 16 ga. ) that carries a 19 ga., 1.25 cm long needle at the end. The Kumar Catheter® is used to puncture the Hartmann's pouch of the gallbladder for biliary access and / or aspiration. Product is latex free. FDA UDI
- Model / Reference
- CC019 FDA UDI
- Description
- The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholangiography. It comprises a translucent tubing ( 76 cm. length and 16 ga. ) that carries a 19 ga., 1.25 cm long needle at the end. The Kumar Catheter® is used to puncture the Hartmann's pouch of the gallbladder for biliary access and / or aspiration. Product is latex free. FDA UDI
Identifiers
- Catalog Number
- CC-019 FDA UDI
- Primary DI / UDI-DI
- B361CC0190 FDA UDI
- 510(k) Number
- K973621 FDA UDI
- FDA Product Code
- GBZ FDA UDI
- GMDN Term
- Laparoscopic cholangiography injection catheter/needle 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
Yes
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
Category: Laparoscopic cholangiography injection catheter/needle
Kumar Catheter® by Nashville Surgical Instruments — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Nashville Surgical Instruments
Sources (1)
- FDA UDI b243bd66-2330-4f16-ad1a-0f037f481d94 37 fields · synced May 30, 2026