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Paragon 8F Balloon Guide Cathete

FDA UDI

Class II (US FDA UDI)

by Shanghai Wallaby Medical Technologies Co., Inc.

Identity

Trade Name
Paragon 8F Balloon Guide Cathete FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Model / Reference
BG8F085 FDA UDI

Identifiers

Primary DI / UDI-DI
06970908212093 FDA UDI
FDA Product Code
DQY FDA UDI
QJP 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

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

No

FDA UDI

Category: Intravascular occluding balloon catheter, image-guided

Paragon 8F Balloon Guide Cathete by Shanghai Wallaby Medical Technologies Co., Inc. — 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
Shanghai Wallaby Medical Technologies Co., Inc.

Sources (1)

  • FDA UDI 1dc4b887-27c9-41fa-9da2-0497d8b507f6 32 fields · synced May 30, 2026