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Disposable Sure-Flex Biliary Balloon Dilatation Catheter

FDA UDI

Class II (US FDA UDI)

by TeleMed Systems

Identity

Trade Name
Disposable Sure-Flex Biliary Balloon Dilatation Catheter FDA UDI
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Device Name
Biliary Dilator 8mm Diameter x 4cm Length Balloon Dimension 180cm Total Catheter Length FDA UDI
Model / Reference
1344 FDA UDI
Description
Biliary Dilator 8mm Diameter x 4cm Length Balloon Dimension 180cm Total Catheter Length FDA UDI

Identifiers

Primary DI / UDI-DI
00813353010097 FDA UDI
510(k) Number
K901432 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
Commercial Distribution
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

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: Gastrointestinal/biliary dilation balloon catheter, non-medicated

Disposable Sure-Flex Biliary Balloon Dilatation Catheter by TeleMed Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.

Cleared under the same submission

K901432 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
TeleMed Systems

Sources (1)

  • FDA UDI 0fcb0c08-0eca-40aa-b480-75c51ed611b9 34 fields · synced May 30, 2026