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Sofia 88

FDA UDI

Class II (US FDA UDI)

by Microvention Inc.

Identity

Trade Name
SOFIA 88 FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
SOFIA 88 - 115cm FDA UDI
Model / Reference
DA8115ST-DAC-US FDA UDI
Description
SOFIA 88 - 115cm FDA UDI

Identifiers

Catalog Number
DA8115ST FDA UDI
Primary DI / UDI-DI
00842429117705 FDA UDI
510(k) Number
K214024 FDA UDI
FDA Product Code
DQY FDA UDI
QJP 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

Yes

FDA UDI

Category: Vascular guide-catheter, single-use

Sofia 88 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

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Manufacturer

Manufacturer
Microvention Inc.

Sources (1)

  • FDA UDI 166e158b-e3bc-4a42-b1a8-2b99db08f6a0 37 fields · synced Jun 8, 2026