Arrive™ Braided Transseptal Sheath 990079-055

GUDID 00643169530621

Braided Transseptal Sheath, 10F

Oscor Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00643169530621
• NIH Device Record Key: 5e0c9a2a-ad7b-48b6-b9e9-7bcb296b8400
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arrive™ Braided Transseptal Sheath
• Version Model Number: 990079-055
• Catalog Number: 990079-055
• 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

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
• 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
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com

Device Dimensions

• Length: 79 Centimeter
• Length: 79 Centimeter
• Length: 79 Centimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 Centimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 79 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
• 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	00643169530621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101497

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-11-21

On-Brand Devices [Arrive™ Braided Transseptal Sheath]

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• 00643169530638: Braided Transseptal Sheath, 10F
• 00643169530621: Braided Transseptal Sheath, 10F
• 00643169530614: Braided Transseptal Sheath, 10F
• 00643169530591: Braided Transseptal Sheath, 10F
• 00643169530584: Braided Transseptal Sheath, 10F