FDA.report

Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet

Primary DI
10801741030380
Brand
Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet
Company
C. R. Bard, Inc.
Model
190500
Catalog number
190500
Device description
Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet for use with Bard® Nephrostomy Short Tip Councill Catheters
Published
2016-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741030380PackageGS15In Commercial Distribution
00801741030383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103038010801741030380
00801741030383008017410303838017410303830801741030383

GMDN Terms

TermDefinition
Suprapubic needle, surgical, single-useA hand-held manual surgical instrument designed with a sharp pyramidal or conical point at the distal end to percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair, typically to position a sling used in the treatment of female stress urinary incontinence (SUI) associated with a bladder prolapse. The needle is typically made of a high-grade stainless steel rod (curved or malleable) with a pointed tip and an eye or notch at the distal end to help position the sling. This device can be made of metal and/or synthetic materials. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge6French

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags

DUNS number
016898496
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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