Steady Sheath

SteadySheath Shortie 11 Fr Evolution Tissue Stabilization Sheath

Registry build 21.09.26
1manufacturer
5catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code DRE
Manufacturer City Province Registered as Device types
Lifetech Scientific (Shenzhen) Co,.ltd Shenzhen Guangdong Manufacturer 3

Record

Regulatory record for Steady Sheath
Listed by Cook Vandergrift Inc., United States
FDA product code DRE
Device type Dilator, Vessel, For Percutaneous Catheterization
Device class Class 2
Regulation 21 CFR 870.1310
Establishment Complaint-file establishment, Manufacturer
Record published 2016-09-24
Record revised 2018-06-20 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Store in dark, dry, cool place.

Catalogue Numbers

Catalogue numbers for Steady Sheath
Catalogue number Size Status
G25083 In distribution
G31908 In distribution
G25084 In distribution
G31923 In distribution
G25082 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Prelude® Merit Medical Systems, Inc. 323
Prelude PRO™ Merit Medical Systems, Inc. 132
Cook Cook Incorporated 125
Avanti Cordis Corp. 81
Dilator, Vessel, For Percutaneous Catheterization B. Braun Interventional Systems, Inc. 59
Merit MAK™ Merit Medical Systems, Inc. 49
Prelude ACT™ Merit Medical Systems, Inc. 38
AngioDynamics Navilyst Medical, Inc. 38
Super Sheath Togo Medikit Co., Ltd. 31
Avanti Cordis US Corp. 29
Mini Stick MAX AngioDynamics, Inc. 28
OneStic Micro-Access Introducer Argon Medical Devices, Inc. 27

Showing 12 of 159. All products under Dilator, Vessel, For Percutaneous Catheterization

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer