XenMatrix AB Surgical Graft 1152020

GUDID 00801741074295

XenMatrix AB Surgical Graft

Davol Inc.

Abdominal hernia surgical mesh, collagen, antimicrobial

• Primary Device ID: 00801741074295
• NIH Device Record Key: 99a48a05-139c-42e0-bbc7-2a0c9b58f270
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XenMatrix AB Surgical Graft
• Version Model Number: 1152020
• Catalog Number: 1152020
• 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: true
• 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@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
• 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
• 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: 20 Centimeter
• Length: 20 Centimeter
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• Width: 20 Centimeter
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Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741074295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133223

FDA Product Code

• PIJ: Collagen surgical mesh containing drugs

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: 2014-10-23

On-Brand Devices [XenMatrix AB Surgical Graft]

• 00801741129049: XenMatrix AB Surgical Graft
• 00801741129032: XenMatrix AB Surgical Graft
• 00801741129025: XenMatrix AB Surgical Graft
• 00801741129018: XenMatrix AB Surgical Graft
• 00801741129001: XenMatrix AB Surgical Graft
• 00801741128998: XenMatrix AB Surgical Graft
• 00801741128981: XenMatrix AB Surgical Graft
• 00801741128974: XenMatrix AB Surgical Graft
• 00801741074301: XenMatrix AB Surgical Graft
• 00801741074295: XenMatrix AB Surgical Graft
• 00801741074288: XenMatrix AB Surgical Graft
• 00801741074271: XenMatrix AB Surgical Graft
• 00801741074264: XenMatrix AB Surgical Graft
• 00801741074257: XenMatrix AB Surgical Graft
• 00801741074240: XenMatrix AB Surgical Graft
• 00801741074233: XenMatrix AB Surgical Graft
• 00801741074226: XenMatrix AB Surgical Graft
• 00801741074219: XenMatrix AB Surgical Graft
• 00801741074202: XenMatrix AB Surgical Graft
• 00801741074196: XenMatrix AB Surgical Graft
• 00801741074189: XenMatrix AB Surgical Graft
• 00801741074172: XenMatrix AB Surgical Graft