LS-14

GUDID 00885672103569

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: 00885672103569
• NIH Device Record Key: be65f8fc-63e2-49d8-bc61-e702bf4928d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LS-14
• Version Model Number: LS-14
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672103569 [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: 4
• Public Version Date: 2018-08-07
• Device Publish Date: 2015-10-16

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• 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