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Banner Balloon Guide Catheter

FDA UDI

Class II (US FDA UDI)

by Eosolutions, Corp.

Identity

Trade Name
Banner Balloon Guide Catheter FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Device Name
Banner Balloon Guide Catheter FDA UDI
Model / Reference
INC-12098 FDA UDI
Description
Banner Balloon Guide Catheter FDA UDI

Identifiers

Catalog Number
INC-12098 FDA UDI
Primary DI / UDI-DI
08600092100040 FDA UDI
510(k) Number
K220331 FDA UDI
FDA Product Code
QJP FDA UDI
DQY FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

No

FDA UDI

Category: Intravascular occluding balloon catheter, image-guided

Banner Balloon Guide Catheter by Eosolutions, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular occluding balloon catheter, image-guided.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eosolutions, Corp.

Sources (1)

  • FDA UDI a3969645-ad21-4efe-ada0-745b13ac5199 36 fields · synced May 30, 2026