SCOUT 08650101S

GUDID H98108650101S0

SCOUT VESSEL GUARD 65MM X 55MM X 1MM-STERILE

SYNTHES (U.S.A.) LP

Cardiovascular patch, synthetic

• Primary Device ID: H98108650101S0
• NIH Device Record Key: b6fa36c4-1f75-4a32-801b-fd0bcc82e1a3
• Commercial Distribution Discontinuation: 2018-04-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SCOUT
• Version Model Number: 08.650.101S
• Catalog Number: 08650101S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034753799 [Primary]
HIBCC	H98108650101S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103558

FDA Product Code

• OMR: Vessel guard or cover

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: 2021-02-05
• Device Publish Date: 2015-09-14

On-Brand Devices [SCOUT]

• H98108650102S0: SCOUT VESSEL GUARD 65MM X 110MM X 1MM-STERILE
• H98108650101S0: SCOUT VESSEL GUARD 65MM X 55MM X 1MM-STERILE