Ligature Sleeve LS-21

GUDID 00836559002000

Oscor Inc.

Pacing/defibrillation lead suture sleeve

• Primary Device ID: 00836559002000
• NIH Device Record Key: a3714a75-25d0-43ea-af70-6c2fbee581cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ligature Sleeve
• Version Model Number: LS-21
• Catalog Number: LS-21
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836559002000 [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

On-Brand Devices [Ligature Sleeve]

• 70836559007424: LS17B20
• 70836559002023: LS26B20
• 70836559002016: LS24B20
• 70836559002009: LS21B20
• 70836559001996: LS18B20
• 70836559001989: LS15B20
• 20885672008349: Ligature Sleeve
• 20802526563229: 664760-302
• 00836559007425: LS-17
• 00836559002024: LS-26
• 00836559002017: LS-24
• 00836559002000: LS-21
• 00836559001997: LS-18
• 00836559001980: LS-15