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Axsos

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
AXSOS FDA UDI
Generic Name
Temporary cardiac pacing balloon catheter FDA UDI
Device Name
K-Wire Drill Tip FDA UDI
Model / Reference
705002 FDA UDI
Description
K-Wire Drill Tip FDA UDI

Identifiers

Catalog Number
705002 FDA UDI
Primary DI / UDI-DI
07613327086157 FDA UDI
FDA Product Code
HWE FDA UDI
GMDN Term
Temporary cardiac pacing balloon catheter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 234.0 Millimeter FDA UDI

Category: Temporary cardiac pacing balloon catheter

Axsos by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary cardiac pacing balloon catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 563c0bcc-e13a-47ce-9877-ef9d6064a609 35 fields · synced May 30, 2026