Proxis™ Ureteral Access Sheath

Primary DI
00801741101700
Brand
Proxis™ Ureteral Access Sheath
Company
C. R. Bard, Inc.
Model
231225
Catalog number
231225
Device description
Proxis™ Ureteral Access Sheath
Published
2016-07-26
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
FEDendoscopic access overtube, gastroenterology-urology

Product Code Classifications

CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741101700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741101700008017411017008017411017000801741101700

GMDN Terms

TermDefinition
Ureteral dilatation/injection catheterA sterile, flexible or semi-flexible tube designed to be inserted through the urethra to open or increase the diameter of a constricted or irregular ureteral passage and allow the injection of a contrast medium to access possible submucosal tunnelling. The device is typically made of plastic materials and is available in a variety of diameters and lengths. It may also be used for the injection of a topical anaesthetic; other instruments may be passed through this device. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge14French
Length25Centimeter

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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