IS4/DF4 PLUG

GUDID 00885672007003

Oscor Inc.

Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug

• Primary Device ID: 00885672007003
• NIH Device Record Key: 6c12a691-c7e7-4b2f-9830-8ae6863f4ebf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IS4/DF4 PLUG
• Version Model Number: IS4/DF4 PLUG
• 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
• 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	00885672007003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143463

FDA Product Code

• DTD: Pacemaker Lead Adaptor

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: 2018-08-07
• Device Publish Date: 2015-10-16

On-Brand Devices [IS4/DF4 PLUG]

• 00885672008260: 667148-300
• 00885672007003: IS4/DF4 PLUG