Avitene 1020010

GUDID 10801741223102

Avitene Flowable Collagen Hemostat

Davol Inc.

Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial

• Primary Device ID: 10801741223102
• NIH Device Record Key: d80936bb-01d7-4e5e-91f7-d257ab07c821
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avitene
• Version Model Number: 1020010
• Catalog Number: 1020010
• Company DUNS: 001191048
• Company Name: Davol Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741223105 [Primary]
GS1	10801741223102 [Package]; Contains: 00801741223105; Package: EA [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: N17600

FDA Product Code

• LMF: Agent, absorbable hemostatic, collagen based

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: 2023-07-05
• Device Publish Date: 2023-06-27

Devices Manufactured by Davol Inc.

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• 10801741223102 - Avitene: 2023-07-05Avitene Flowable Collagen Hemostat
• 10801741223102 - Avitene: 2023-07-05 Avitene Flowable Collagen Hemostat
• 00801741200748 - 3DMax™ MID Anatomical Mesh: 2020-08-04 3DMax™ MID Anatomical Mesh, Medium, Left, 3" x 5", 8 x 13 cm
• 00801741200755 - 3DMax™ MID Anatomical Mesh: 2020-08-04 3DMax™ MID Anatomical Mesh, Large, Left, 4" x 6", 10 x 16 cm
• 00801741200762 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, XL, Left, 5” x 7”, 12 x 17 cm
• 00801741200779 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, Medium, Right, 3" x 5", 8 x 13 cm
• 00801741200786 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, Large, Right, 4” x 6”, 10 x 16 cm
• 00801741200793 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, XL, Right, 5” x 7”, 12 x 17 cm