COOK LR-STS001

GUDID 00827002200067

Stylet Wires

Cook Vandergrift Inc.

Pacing lead extraction kit, single-use

• Primary Device ID: 00827002200067
• NIH Device Record Key: 46091fcd-4003-4f36-b08d-11dbec3b2e95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COOK
• Version Model Number: G20006
• Catalog Number: LR-STS001
• 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	00827002200067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170298

FDA Product Code

• DRB: STYLET, CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-20
• Device Publish Date: 2018-07-20

On-Brand Devices [COOK]

• 00827002554580: Charger For Blood Flow Monitor - DP-M350 - Non-Sterile
• 00827002553286: Blood Flow Monitor - Non-Sterile
• 10827002328218: Micro-Injection Pipette
• 10827002328188: Micro-Injection Pipette
• 10827002328171: Micro-Injection Pipette
• 10827002328140: Micro-Injection Pipette
• 10827002328133: Micro-Injection Pipette
• 10827002328126: Holding Pipette
• 10827002328102: Holding Pipette
• 10827002328072: Holding Pipette
• 10827002328065: Holding Pipette
• 10827002328027: Holding Pipette
• 10827002328010: Holding Pipette
• 10827002327990: Blastomere Aspiration Pipette (Embryo Biopsy Pipette)
• 10827002327952: Blastomere Aspiration Pipette (Embryo Biopsy Pipette)
• 00827002316324: Doppler Blood Flow Monitor Channel/Cable Verifier - Non-Sterile
• 10827002266848: Micro-Injection Pipette
• 00827002265660: Curved 16 Fr Introducer Sheath set - Femoral
• 00827002265059: Curved Inner Femoral Sheath
• 00827002200067: Stylet Wires
• 10827002180908: Micro-Injection Pipette
• 10827002583419: Pin Vise Polymer
• 10827002610153: G61015
• 10827002610146: G61014
• 10827002610139: G61013
• 10827002609898: G60989