Hemacarotid Patch HEK14/75CPUT (1)

GUDID 00384401001508

Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch

INTERVASCULAR SAS

Cardiovascular patch, animal-derived

• Primary Device ID: 00384401001508
• NIH Device Record Key: f16b067c-8042-42be-b4be-a5906a49621a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemacarotid Patch
• Version Model Number: HEK14/75CPUT (1)
• Catalog Number: HEK14/75CPUT (1)
• Company DUNS: 382174019
• Company Name: INTERVASCULAR SAS
• 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: true
• 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: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com

Device Dimensions

• Length: 75 Micrometer
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer
• Width: 14 Millimeter
• Length: 75 Micrometer

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384401001508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983819

FDA Product Code

• DSY: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Hemacarotid Patch]

• 00384401010715: Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
• 00384401010708: Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
• 00384401001508: Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
• 00384401001492: Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
• 00384401001485: Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
• 00384401001478: Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
• 00384401001461: Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
• 00384401001454: Hemacarotidpatch Knitted Collagen Coated Vascular Patch
• 00384401001447: Hemacarotidpatch Knitted Collagen Coated Vascular Patch
• 00384401001430: Hemacarotidpatch Knitted Collagen Coated Vascular Patch
• 00384401001423: Hemacarotidpatch Knitted Collagen Coated Vascular Patch
• 00384401001416: Hemacarotidpatch Knitted Collagen Coated Vascular Patch
• 00384401011248: Hemacarotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
• 00384401011224: Hemacarotid Patch Knitted Ultrathin Collagen Coated Vascular Patch