← Back to catalogue

ReverseTM

FDA UDI

Class II (US FDA UDI)

by Reverse Medical Corporation

Identity

Trade Name
ReverseTM FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
MICROCATHETER MIC-021-150 REVERSE FDA UDI
Model / Reference
MIC-021-150 FDA UDI
Description
MICROCATHETER MIC-021-150 REVERSE FDA UDI

Identifiers

Primary DI / UDI-DI
00847536021945 FDA UDI
510(k) Number
K122684 FDA UDI
FDA Product Code
DQY FDA UDI
KRA FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
870.1210 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Vascular guide-catheter, single-use

ReverseTM by Reverse Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K122684 also covers:

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
Reverse Medical Corporation

Sources (1)

  • FDA UDI e11a4735-9583-4a02-a55e-e0f59bbdcd58 36 fields · synced May 29, 2026