ARISTA AH FlexiTip XL-R AM0010

GUDID 10801741096805

ARISTA AH FlexiTip XL-R Applicator

Davol Inc.

Atomizing surgical topical solution applicator

• Primary Device ID: 10801741096805
• NIH Device Record Key: 9b5d672b-bae9-4e59-88df-8128dc0c7a20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARISTA AH FlexiTip XL-R
• Version Model Number: AM0010
• Catalog Number: AM0010
• Company DUNS: 001191048
• Company Name: Davol 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: 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@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com

Device Dimensions

• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter
• Length: 38 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741096808 [Primary]
GS1	10801741096805 [Package]; Contains: 00801741096808; Package: CA [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050038

FDA Product Code

• LMG: Agent, absorbable hemostatic, non-collagen based

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: 2016-01-25

Devices Manufactured by Davol Inc.

• 20801741044063 - ARISTA: 2024-10-22 Arista AH FlexiTip Applicator, 14 cm (5.5 in)
• 10801741044080 - HemaDerm: 2023-10-17 ENT Kit with HemaDerm Topical 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