XenMatrix AB Surgical Graft 1150616

GUDID 00801741074196

XenMatrix AB Surgical Graft

Davol Inc.

Abdominal hernia surgical mesh, collagen, antimicrobial Abdominal hernia surgical mesh, collagen, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial

Primary Device ID	00801741074196
NIH Device Record Key	5624a76b-ac5f-4230-8fe1-30c3cf96489b
Commercial Distribution Status	In Commercial Distribution
Brand Name	XenMatrix AB Surgical Graft
Version Model Number	1150616
Catalog Number	1150616
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

Device Dimensions

Length	6 Centimeter
Length	6 Centimeter
Length	6 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter
Width	16 Centimeter
Length	6 Centimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741074196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K133223

FDA Product Code

OXH	Mesh, surgical, collagen, plastic and reconstructive surgery

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

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