FDA.reportPublic FDA data

SureStep Intermittent Catheter Tray

Primary DI
10801741183314
Brand
SureStep Intermittent Catheter Tray
Company
C. R. Bard, Inc.
Model
INTAAI
Catalog number
INTAAI
Device description
SureStep Intermittent Catheter Tray
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHRCatheter care tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741183314PackageGS120In Commercial Distribution
00801741183317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174118331410801741183314
00801741183317008017411833178017411833170801741183317

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
true
Combination product
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741045943Bard® DigniShield® Stool Management SystemSMS002SMS0022016-08-25
00801741050930Fecal Containment Device1900111900112020-09-22
00801741113147Bard® DigniShield® Stool Management System with ENFit™ENSMS002ENSMS0022016-11-03
00801741050817Leg Bag1505071505072020-09-23
00801741076039Catheter Stabilization DeviceVFDSPVFDSP2020-09-22
00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
00801741076145Catheter Stabilization DeviceFOL0105FOL01052020-09-22
00801741127625Bard® Leg Bag Holders1501111501112016-08-10
00801741127632Bard® Leg Bag Holders1501211501212016-08-10
00801741127649Bard® Leg Bag Holders1501311501312016-08-10
00801741137419Bard® Wide Leg Bag Straps1621101621102018-02-06
00801741137426Bard® Wide Leg Bag Straps1622101622102018-02-06
00801741137433Bard® Wide Leg Bag Straps1623101623102018-02-06
00801741215902StatLock UrologicalSTATURO25STATURO252020-10-23
00801741231025PureWickPW300PCPW300PC2026-05-07
00801741234514PureWickPWA300HPWA300H2026-05-07
00801741225239Elyra708200170820012026-05-06

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Primary DI, Brand, Company table
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