← Back to catalogue

Sofia 6F-125cm STR

FDA UDI

Class II (US FDA UDI)

by Microvention Inc.

Identity

Trade Name
Sofia 6F-125cm STR FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
Stroke Access FDA UDI
Model / Reference
DA6125ST FDA UDI
Description
Stroke Access FDA UDI

Identifiers

Catalog Number
DA6125ST FDA UDI
Primary DI / UDI-DI
00812636020426 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Vascular guide-catheter, single-use

Sofia 6F-125cm STR by Microvention 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
Microvention Inc.

Sources (1)

  • FDA UDI 3bd10d33-38e2-4198-99f7-9a2ad2b38e7c 36 fields · synced Jun 8, 2026