FDA.reportPublic FDA data

COVA ORTHO NERVE

Primary DI
03760193182583
Brand
COVA ORTHO NERVE
Company
DILON TECHNOLOGIES FRANCE
Model
MCG 14 46 AD
Catalog number
COUS46
Device description
Collagen Guided Healing Membrane
Published
2016-11-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXICuff, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXICuff, NerveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103081000COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANEBiom'Up Sas2012-03-02JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760193182583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760193182583037601931825833760193182583

GMDN Terms#

Term, Definition table
TermDefinition
Surgical anti-adhesion material, implantable, bioabsorbable, non-medicatedA bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue and another following a surgical procedure; neither antimicrobials nor pharmaceuticals are included. It may be supplied as a barrier membrane, hydratable gel, or fluid dressing and is made of appropriate material (e.g., collagen- or hyaluronic acid-based) to reduce adhesion between adjacent anatomical structures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter
Width40Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Dry place away from humidity
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33486573610xx@xx.xx

Regulatory Flags#

DUNS number
279346203
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760193182668HEMOBLAST Bellows Laparoscopic ApplicatorLAP01-USLAP01-US2019-02-28
03760193182705HEMOBLAST BellowsBQF02BQF02-US2018-03-19
03760193181975SALVIN RENOVIXMCG 11 12 URENOVIX-15x252016-02-25
03760193181982SALVIN RENOVIXMCG 12 23 URENOVIX-20x302016-02-25
03760193181999SALVIN RENOVIXMCG 13 34 URENOVIX-30x402016-02-25
03760193182019COVAORTHO-NERVEMCG 11 12 VCOVO122016-02-25
03760193182026COVAORTHO-NERVEMCG 12 23 VCOVO232016-02-25
03760193182033COVAORTHO-NERVEMCG 13 34 VCOVO342016-02-25
03760193182040COVAORTHO-NERVEMCG 14 46 VCOVO462016-02-25
03760193182057COVAORTHO-NERVEMCG 15 68 VCOVO682016-11-28
03760193182194COVAMAXMCG 11 12 AACOV12DUS2016-02-22
03760193182200COVAMAXMCG 12 23 AACOV23DUS2016-02-25
03760193182217COVAMAXMCG 13 34 AACOV34DUS2016-02-25
03760193182552COVA ORTHO NERVEMCG 11 12 ADCOUS122016-11-28
03760193182569COVA ORTHO NERVEMCG 12 23 ADCOUS232016-11-28
03760193182576COVA ORTHO NERVEMCG 13 34 ADCOUS342016-11-28
03760193182590COVA ORTHO NERVEMCG 15 68 ADCOUS682016-11-28
03760193182088COVAMESHMSH 08 D12 VCVM12RUS2016-02-25
03760193182095COVAMESHMSH 09 1510 VCVM1510US2016-02-26
03760193182101COVAMESHMSH 10 2015 VCVM2015US2016-02-26

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