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Evolution

FDA UDI

Class II (US FDA UDI)

by Cook Vandergrift Inc.

Identity

Trade Name
Evolution FDA UDI
Generic Name
Fascial tissue dilator, single-use FDA UDI
Device Name
Evolution RL 9 Fr Controlled-Rotation Dilator Sheath Set FDA UDI
Model / Reference
G23737 FDA UDI
Description
Evolution RL 9 Fr Controlled-Rotation Dilator Sheath Set FDA UDI

Identifiers

Catalog Number
LR-EVN-9.0-RL FDA UDI
Primary DI / UDI-DI
10827002237374 FDA UDI
FDA Product Code
DRE FDA UDI
GMDN Term
Fascial tissue dilator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1310 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: Fascial tissue dilator, single-use

Evolution by Cook Vandergrift Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fascial tissue dilator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Vandergrift Inc.

Sources (1)

  • FDA UDI b3e4eea9-7c99-4b8a-817d-c9122a9a9933 36 fields · synced May 30, 2026