Integra® DuraFlex™ Suturable Dural Graft BP11216

GUDID 10381780074250

Integra® DuraFlexTM Suturable Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.

Integra Lifesciences Corporation

Dura mater graft, bovine

Primary Device ID	10381780074250
NIH Device Record Key	ebf244f7-3d06-4400-abf6-aee10a3d74af
Commercial Distribution Status	In Commercial Distribution
Brand Name	Integra® DuraFlex™ Suturable Dural Graft
Version Model Number	BP11216
Catalog Number	BP11216
Company DUNS	083171244
Company Name	Integra Lifesciences Corporation
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	true
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)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com

Device Dimensions

Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter
Length	12 Centimeter
Width	16 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry Keep away from sunlight
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780074250 [Previous]
GS1	10381780511373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K132850

FDA Product Code

GXQ	DURA SUBSTITUTE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-09-22
Device Publish Date	2019-02-22

On-Brand Devices [Integra® DuraFlex™ Suturable Dural Graft]

10381780074250	Integra® DuraFlexTM Suturable Dural Graft is a natural, resorbable, collagenous device for use
10381780074243	Integra® DuraFlexTM Suturable Dural Graft is a natural, resorbable, collagenous device for use
10381780074236	Integra® DuraFlexTM Suturable Dural Graft is a natural, resorbable, collagenous device for use
10381780074229	Integra® DuraFlexTM Suturable Dural Graft is a natural, resorbable, collagenous device for use
10381780074212	Integra® DuraFlexTM Suturable Dural Graft is a natural, resorbable, collagenous device for use

Trademark Results [Integra]

Mark Image Registration \| Serial	Company Trademark Application Date
INTEGRA 98465614 not registered Live/Pending	Cleveland-Cliffs Inc. 2024-03-25
INTEGRA 98382495 not registered Live/Pending	Universal Instruments Corporation 2024-01-30
INTEGRA 98155011 not registered Live/Pending	Integra Mission Critical, LLC 2023-08-29
INTEGRA 97870354 not registered Live/Pending	CROWN PACKAGING TECHNOLOGY, INC. 2023-04-03
INTEGRA 97711737 not registered Live/Pending	Honda Motor Co., Ltd. 2022-12-09
INTEGRA 97640152 not registered Live/Pending	Integra LifeSciences Corporation 2022-10-20
INTEGRA 97636638 not registered Live/Pending	POLYSOURCE, INC. 2022-10-18
INTEGRA 97060638 not registered Live/Pending	Nordson Corporation 2021-10-05
INTEGRA 90894598 not registered Live/Pending	Honda Motor Co. Ltd. 2021-08-20
INTEGRA 90880335 not registered Live/Pending	Honda Motor Co. Ltd. 2021-08-12
INTEGRA 88947894 not registered Live/Pending	Horton Point LLC 2020-06-04
INTEGRA 88794888 not registered Live/Pending	Interior Design Group 2020-02-12