ARISTA AH FlexiTip XL-R AM0010

GUDID 10801741096805

ARISTA AH FlexiTip XL-R Applicator

Davol Inc.

Atomizing surgical topical solution applicator 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

Device Dimensions

• 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

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