53912D Disposable Extension Cable 53912D

GUDID 00885672010041

Disposable Extension Cable

Oscor Inc.

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• Primary Device ID: 00885672010041
• NIH Device Record Key: 1c82960e-5918-4bce-b99c-87a128cc426b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 53912D Disposable Extension Cable
• Version Model Number: 53912D
• Catalog Number: 53912D
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• Device Count: 5
• DM Exempt: true
• 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(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com

Device Dimensions

• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter
• Length: 20 Centimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672010041 [Unit of Use]
GS1	10885672010048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070926

FDA Product Code

• IKD: CABLE, ELECTRODE

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: 2020-08-18
• Device Publish Date: 2020-08-10

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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