Steady Sheath LR-TSS-9.0

GUDID 00827002250826

SteadySheath 9 Fr Evolution Tissue Stabilization Sheath

Cook Vandergrift Inc.

Fascial tissue dilator, single-use

• Primary Device ID: 00827002250826
• NIH Device Record Key: 3e33ee72-4c2e-499d-8a4e-acc9399f9763
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steady Sheath
• Version Model Number: G25082
• Catalog Number: LR-TSS-9.0
• Company DUNS: 056867526
• Company Name: Cook Vandergrift Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002250826 [Primary]

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-20
• Device Publish Date: 2016-09-24

On-Brand Devices [Steady Sheath]

• 00827002319233: SteadySheath Shortie 11 Fr Evolution Tissue Stabilization Sheath
• 00827002319080: SteadySheath Shortie 9 Fr Evolution Tissue Stabilization Sheath
• 00827002250840: SteadySheath 13 Fr Evolution Tissue Stabilization Sheath
• 00827002250833: SteadySheath 11 Fr Evolution Tissue Stabilization Sheath
• 00827002250826: SteadySheath 9 Fr Evolution Tissue Stabilization Sheath