FDA.reportPublic FDA data

Kumar Catheter®

Primary DI
B361CC0190
Brand
Kumar Catheter®
Company
NASHVILLE SURGICAL INSTRUMENTS, LLC
Model
CC019
Catalog number
CC-019
Device 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.
Published
2017-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBZCatheter, Cholangiography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBZCatheter, CholangiographyGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973621000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973621000PRE-VIEW CHOLANGIOGRAPHY CLAMPNashville Surgical Instruments1997-12-17GBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B361CC0191PackageHIBCC20In Commercial Distribution
B361CC0190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic cholangiography catheter/needleA sterile, flexible, single-lumen tube with a distal needle intended to puncture the neck of the gallbladder (Hartmann¿s pouch) during laparoscopic cholangiography to allow injection of contrast media. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature45 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
615-382-4996orders@nashvillesurg.com

Regulatory Flags#

DUNS number
030096122
Device count
1
DM exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B361KC0020Kumar Clamp®KC-002KC-0022017-08-15
B361KC2XL0Kumar Clamp® for Single Port, Bariatrics and RoboticsKC2XLKC-2XL2017-08-15
B361TA0080Kumar T-ANCHORS® Hernia SetTA-008TA-0082017-08-15

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Primary DI, Brand, Company table
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