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Cook

FDA UDI

Class I (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Cook FDA UDI
Generic Name
Neural-tissue balloon catheter FDA UDI
Device Name
Mini Compression Balloon Catheter with Silicone Balloon FDA UDI
Model / Reference
G10324 FDA UDI
Description
Mini Compression Balloon Catheter with Silicone Balloon FDA UDI

Identifiers

Catalog Number
MCB-3.0-CE-60 FDA UDI
Primary DI / UDI-DI
00827002103245 FDA UDI
FDA Product Code
HAO FDA UDI
GMDN Term
Neural-tissue balloon catheter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4535 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Neural-tissue balloon catheter

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

Similar devices

Also classified as Neural-tissue balloon catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI 6ae9be90-0cc8-4434-bcab-6a424e3e0305 36 fields · synced Jun 8, 2026