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Silicone Supra-Pubic Catheter Puncture Set (Integrated Balloon)

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 4890-9214Ref 4890-9212

by Fortune Medical Instrument Corp.

Identity

Trade Name
Silicone Supra-Pubic Catheter Puncture Set EUDAMED
Silicone Supra-Pubic Catheter Puncture Set (Integrated Balloon) FDA UDI
Generic Name
Suprapubic drainage catheter FDA UDI
Device Name
Silicone Supra-Pubic Catheter Puncture Set EUDAMED
Model / Reference
4890-9212 EUDAMEDFDA UDI
4890-9214 EUDAMED

Identifiers

Primary DI / UDI-DI
04710961937685 EUDAMEDFDA UDI
14710961937699 EUDAMED
Basic UDI-DI
B-14710961937699 EUDAMED
B-04710961937685 EUDAMED
510(k) Number
K014002 FDA UDI
FDA Product Code
KOB FDA UDI
EMDN Code
U040101 KITS WITH DRAINAGE CATHETERS, DIRECT PUNCTURE EUDAMED
GMDN Term
Suprapubic drainage catheter FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
876.5090 FDA UDI
Market of Registration
Belgium EUDAMED
Czechia EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI

Category: Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Puncture Set (Integrated Balloon) by Fortune Medical Instrument Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Suprapubic drainage catheter.

Cleared under the same submission

K014002 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fortune Medical Instrument Corp.

Sources (3)

  • FDA UDI e37c0dc4-3cf4-401b-8e35-652906a39551 33 fields · synced Jul 28, 2026
  • EUDAMED e30ee307-8d87-4d0e-958e-faff23768a73 61 fields · synced Jul 22, 2026
  • EUDAMED a2fdcc4f-05c4-4b19-9e77-afcc50ca6571 61 fields · synced Jul 28, 2026