FDA.reportPublic FDA data

COVAORTHO-NERVE

Primary DI
03760193182040
Brand
COVAORTHO-NERVE
Company
DILON TECHNOLOGIES FRANCE
Model
MCG 14 46 V
Catalog number
COVO46
Device description
Collagen Guided Healing Membrane
Published
2016-02-25
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
03760193182040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760193182040037601931820403760193182040

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
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
03760193182583COVA ORTHO NERVEMCG 14 46 ADCOUS462016-11-28
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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Primary DI, Brand, Company table
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