← Back to catalogue

Surefire Flexion Guiding Catheter

FDA UDI

Class II (US FDA UDI)

by Surefire Medical, Inc.

Identity

Trade Name
Surefire Flexion Guiding Catheter FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
80cm, 5F Guiding Catheter with Axis Shape FDA UDI
Model / Reference
SSG-5080-Axis FDA UDI
Description
80cm, 5F Guiding Catheter with Axis Shape FDA UDI

Identifiers

Primary DI / UDI-DI
00857136004149 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Vascular guide-catheter, single-use 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
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 5 French FDA UDI
Lumen/Inner Diameter — 0.054 Inch FDA UDI
Length — 80 Centimeter FDA UDI

Category: Vascular guide-catheter, single-use

Surefire Flexion Guiding Catheter by Surefire Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Surefire Medical, Inc.

Sources (1)

  • FDA UDI 6f03b8ea-1c7b-4762-a56c-361c67503464 34 fields · synced May 31, 2026