LS14B20

GUDID 70885672103568

Oscor Inc.

Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve

• Primary Device ID: 70885672103568
• NIH Device Record Key: 7173fdeb-66e7-4bfb-8efe-736956a54488
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LS14B20
• Version Model Number: LS14B20
• Company DUNS: 101835833
• Company Name: Oscor 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	70885672103568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020669

FDA Product Code

• DTB: Permanent Pacemaker Electrode

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: 2018-07-06
• Device Publish Date: 2015-10-16

Devices Manufactured by Oscor Inc.

• 00885672101466 - Guidewire: 2023-09-15 Guidewire with PTFE coating
• 10885672102576 - ATAR D-R X2L: 2023-09-08 Disposable Extension Cable
• 00885672012489 - Baylis Med Tech Passport Steerable Sheath: 2023-03-23 Passport Steerable Sheath 6.5F
• 00885672012496 - Baylis Med Tech Passport Steerable Sheath: 2023-03-23 Passport Steerable Sheath 6.5F
• 00885672012502 - Baylis Med Tech Passport Steerable Sheath: 2023-03-23 Passport Steerable Sheath 6.5F
• 00885672012519 - Baylis Med Tech Passport Steerable Sheath: 2023-03-23 Passport Steerable Sheath 6.5F
• 00885672012526 - Baylis Med Tech Passport Steerable Sheath: 2023-03-23 Passport Steerable Sheath 6.5F
• 00885672012533 - Baylis Med Tech Passport Steerable Sheath: 2023-03-23 Passport Steerable Sheath 6.5F Dual Dilator