FDA.reportPublic FDA data

SURESTEP

Primary DI
00801741236570
Brand
SURESTEP
Company
C. R. Bard, Inc.
Model
SSPEDINTS10
Catalog number
SSPEDINTS10
Device description
SureStep Intermittent Catheter Tray
Published
2026-10-06
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
KODCatheter, urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741236570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741236570008017412365708017412365700801741236570

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0

Contacts#

Phone, Email table
PhoneEmail
+1(844)823-5433BMD.CS.support@bd.com

Regulatory Flags#

DUNS number
016898496
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741236563SURESTEPSSPEDINTS08SSPEDINTS082026-10-06
00801741236587SURESTEPSSINTL15SSINTL152026-10-06
00801741236594SURESTEPSSINTL16CSSINTL16C2026-10-06
00801741236600SURESTEPSSINTS14SSINTS142026-10-06
00801741236617SURESTEPSSINTS14CSSINTS14C2026-10-06
00801741236624SURESTEPSSINTS16SSINTS162026-10-06
00801741236631SURESTEPSSINTS16CSSINTS16C2026-10-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741236563SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236587SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236600SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236617SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236624SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236631SURESTEPC. R. Bard, Inc.KOD2026-10-06
14026704926944RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704926951RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704926968RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704933843RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704925732RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925749RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925763RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925770RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925787RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925947RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
10192253031782DoverCardinal Health 200, LLCKOD2026-06-18
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253067651DoverCardinal Health 200, LLCKOD2025-04-14
10192253067668DoverCardinal Health 200, LLCKOD2025-04-14
10192253067675DoverCardinal Health 200, LLCKOD2025-04-14
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253066289DoverCardinal Health 200, LLCKOD2024-09-04
10192253066296DoverCardinal Health 200, LLCKOD2024-09-04
10192253066302DoverCardinal Health 200, LLCKOD2024-09-04
10192253066319DoverCardinal Health 200, LLCKOD2024-09-04
10192253066326DoverCardinal Health 200, LLCKOD2024-09-04