← Back to catalogue

Steady Sheath

FDA UDI

Class II (US FDA UDI)

by Cook Vandergrift Inc.

Identity

Trade Name
Steady Sheath FDA UDI
Generic Name
Fascial tissue dilator, single-use FDA UDI
Device Name
SteadySheath 9 Fr Evolution Tissue Stabilization Sheath FDA UDI
Model / Reference
G25082 FDA UDI
Description
SteadySheath 9 Fr Evolution Tissue Stabilization Sheath FDA UDI

Identifiers

Catalog Number
LR-TSS-9.0 FDA UDI
Primary DI / UDI-DI
00827002250826 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

Steady Sheath 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

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

Manufacturer

Manufacturer
Cook Vandergrift Inc.

Sources (1)

  • FDA UDI 3e33ee72-4c2e-499d-8a4e-acc9399f9763 36 fields · synced May 30, 2026