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Advance

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Advance FDA UDI
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Device Name
Advance Biliary Balloon Catheter FDA UDI
Model / Reference
G36347 FDA UDI
Description
Advance Biliary Balloon Catheter FDA UDI

Identifiers

Catalog Number
C-ATB5-35-40-8-4.0-CDES FDA UDI
Primary DI / UDI-DI
00827002363472 FDA UDI
FDA Product Code
GCA 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

Yes

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

Advance by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI b58f4923-7cd8-4172-adcd-51869378be1b 36 fields · synced Jun 8, 2026