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Cobra-Os™

FDA UDI

Class II (US FDA UDI)

by Front Line Medical Technologies Inc.

Identity

Trade Name
COBRA-OS™ FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Device Name
The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage. FDA UDI
Model / Reference
F01P1 FDA UDI
Description
The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage. FDA UDI

Identifiers

Catalog Number
F01P1 FDA UDI
Primary DI / UDI-DI
16286780610016 FDA UDI
510(k) Number
K201652 FDA UDI
FDA Product Code
MJN FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
Not 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

Dimensions & Sizes

Size
Balloon Diameter — 25 Millimeter FDA UDI
Catheter Working Length — 55 Centimeter FDA UDI
Length — 64.9 Centimeter FDA UDI
Balloon Catheter Tip Length — 6.4 Centimeter FDA UDI
Outer Diameter — 1.35 Millimeter FDA UDI

Cobra-Os™ by Front Line Medical Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K201652 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Front Line Medical Technologies Inc.

Sources (1)

  • FDA UDI 93df300d-d9b6-4683-a885-cf998209d1ab 37 fields · synced May 30, 2026