Evolution LR-EVN-SH-11.0-RL

GUDID 00827002237490

Evolution Shortie RL 11 Fr Controlled-Rotation Dilator Sheath Set

Cook Vandergrift Inc.

Fascial tissue dilator, single-use

• Primary Device ID: 00827002237490
• NIH Device Record Key: ace1ef02-e401-4b21-906e-e36fb6c70e17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolution
• Version Model Number: G23749
• Catalog Number: LR-EVN-SH-11.0-RL
• 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	00827002237490 [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 [Evolution]

• 00827002496521: Evolution Shortie 11 Fr Mechanical Dilator Sheath Set
• 00827002496514: Evolution Shortie 9 Fr Mechanical Dilator Sheath Set
• 00827002237490: Evolution Shortie RL 11 Fr Controlled-Rotation Dilator Sheath Set
• 00827002237483: Evolution Shortie RL 9 Fr Controlled-Rotation Dilator Sheath Set