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SureCath

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
SureCath FDA UDI
Generic Name
Single-administration urethral catheterization kit, single-use FDA UDI
Device Name
SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 12/4.0 mm. Vol 700 ml. FDA UDI
Model / Reference
28024 FDA UDI
Description
SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 12/4.0 mm. Vol 700 ml. FDA UDI

Identifiers

Catalog Number
28024 FDA UDI
Primary DI / UDI-DI
05708932021357 FDA UDI
510(k) Number
K973070 FDA UDI
FDA Product Code
EZD FDA UDI
GMDN Term
Single-administration urethral catheterization kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 4 Millimeter FDA UDI
Length — 40 Centimeter FDA UDI
Catheter Gauge — 12 French FDA UDI
Total Volume — 700 Milliliter FDA UDI

SureCath by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K973070 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI c5e52665-cc21-4831-a216-5c632cb4d9d2 39 fields · synced Jun 1, 2026