AlboGraft Polyester Vascular Graft ATC6032

GUDID 00840663110353

AlboGraft® Woven with Collagen 32mm x 60cm

Lemaitre Vascular, Inc.

Synthetic vascular graft

• Primary Device ID: 00840663110353
• NIH Device Record Key: 86756ff1-281a-4b9c-91d1-979dbb1281cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlboGraft Polyester Vascular Graft
• Version Model Number: ATC6032
• Catalog Number: ATC6032
• Company DUNS: 184805166
• Company Name: Lemaitre Vascular, Inc.
• 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: 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: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663110353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103080

FDA Product Code

• MAL: Graft, Vascular, Synthetic/Biologic Composite

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: 2021-06-28
• Device Publish Date: 2021-06-18

On-Brand Devices [AlboGraft Polyester Vascular Graft]

• 00840663107407: AlboGraft Polyester Vascular Graft 60cmx7mm
• 00840663107384: AlboGraft Polyester Vascular Graft 15cmx36mm
• 00840663106677: AlboGraft Polyester Vascular Graft 30cmx36mm
• 00840663104536: AlboGraft Polyester Vascular Graft 60cmx30mm
• 00840663104529: AlboGraft Polyester Vascular Graft 60cmx28mm
• 00840663104512: AlboGraft Polyester Vascular Graft 60cmx26mm
• 00840663104505: AlboGraft Polyester Vascular Graft 60cmx24mm
• 00840663104499: AlboGraft Polyester Vascular Graft 60cmx22mm
• 00840663104482: AlboGraft Polyester Vascular Graft 60cmx20mm
• 00840663104475: AlboGraft Polyester Vascular Graft 60cmx18mm
• 00840663104468: AlboGraft Polyester Vascular Graft 60cmx16mm
• 00840663104451: AlboGraft Polyester Vascular Graft 60cmx14mm
• 00840663104444: AlboGraft Polyester Vascular Graft 60cmx12mm
• 00840663104437: AlboGraft Polyester Vascular Graft 40cmx7mm
• 00840663104420: AlboGraft Polyester Vascular Graft 80cmx10mm
• 00840663104413: AlboGraft Polyester Vascular Graft 80cmx8mm
• 00840663104406: AlboGraft Polyester Vascular Graft 75cmx24mm
• 00840663104390: AlboGraft Polyester Vascular Graft 75cmx22mm
• 00840663104383: AlboGraft Polyester Vascular Graft 75cmx20mm
• 00840663104376: AlboGraft Polyester Vascular Graft 75cmx18mm
• 00840663104369: AlboGraft Polyester Vascular Graft 75cmx16mm
• 00840663104352: AlboGraft Polyester Vascular Graft 75cmx14mm
• 00840663104345: AlboGraft Polyester Vascular Graft 75cmx12mm
• 00840663104338: AlboGraft Polyester Vascular Graft 70cmx10mm
• 00840663104321: AlboGraft Polyester Vascular Graft 70cmx8mm
• 00840663104314: AlboGraft Polyester Vascular Graft 60cmx24mm
• 00840663104307: AlboGraft Polyester Vascular Graft 60cmx22mm
• 00840663104291: AlboGraft Polyester Vascular Graft 60cmx20mm
• 00840663104284: AlboGraft Polyester Vascular Graft 60cmx18mm
• 00840663104277: AlboGraft Polyester Vascular Graft 60cmx16mm
• 00840663104260: AlboGraft Polyester Vascular Graft 60cmx14mm
• 00840663104253: AlboGraft Polyester Vascular Graft 60cmx12mm
• 00840663104246: AlboGraft Polyester Vascular Graft 24cmx12mm
• 00840663104239: AlboGraft Polyester Vascular Graft 22cmx11
• 00840663104222: AlboGraft Polyester Vascular Graft 20cmx11mm
• 00840663104215: AlboGraft Polyester Vascular Graft 20cmx10mm
• 00840663104208: AlboGraft Polyester Vascular Graft 18cmx10mm
• 00840663104192: AlboGraft Polyester Vascular Graft 18cmx9mm
• 00840663104185: AlboGraft Polyester Vascular Graft 16cmx9mm
• 00840663104178: AlboGraft Polyester Vascular Graft 16cmx8mm
• 00840663104161: AlboGraft Polyester Vascular Graft 14cmx8mm
• 00840663104154: AlboGraft Polyester Vascular Graft 14cmx7mm
• 00840663104147: AlboGraft Polyester Vascular Graft 12cmx7mm
• 00840663104109: AlboGraft Polyester Vascular Graft 30cmx38mm
• 00840663104093: AlboGraft Polyester Vascular Graft 15cmx38mm
• 00840663104086: AlboGraft Polyester Vascular Graft 90cmx34mm
• 00840663104079: AlboGraft Polyester Vascular Graft 30cmx34mm
• 00840663104062: AlboGraft Polyester Vascular Graft 15cmx34mm
• 00840663104055: AlboGraft Polyester Vascular Graft 90cmx32mm
• 00840663104048: AlboGraft Polyester Vascular Graft 30cmx32mm