COVA ORTHO NERVE COUS68

GUDID 03760193182590

Collagen Guided Healing Membrane

DILON TECHNOLOGIES FRANCE

Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated

Primary Device ID	03760193182590
NIH Device Record Key	b8c717eb-631d-4e55-b7ba-a4df3abd410a
Commercial Distribution Discontinuation	2019-05-21
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	COVA ORTHO NERVE
Version Model Number	MCG 15 68 AD
Catalog Number	COUS68
Company DUNS	279346203
Company Name	DILON TECHNOLOGIES FRANCE
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	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx
Phone	+33486573610
Email	xx@xx.xx

Device Dimensions

Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter
Length	80 Millimeter
Width	60 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Dry place away from humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760193182590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K103081

FDA Product Code

JXI	Cuff, Nerve

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	8
Public Version Date	2023-10-04
Device Publish Date	2016-11-28

On-Brand Devices [COVA ORTHO NERVE]

03760193182590	Collagen Guided Healing Membrane
03760193182583	Collagen Guided Healing Membrane
03760193182576	Collagen Guided Healing Membrane
03760193182569	Collagen Guided Healing Membrane
03760193182552	Collagen Guided Healing Membrane