FDA.reportPublic FDA data

COVAMESH

Primary DI
03760193182118
Brand
COVAMESH
Company
DILON TECHNOLOGIES FRANCE
Model
MSH 11 2520 V
Catalog number
CVM2520US
Device description
Polyester mesh coated with collagen membrane
Published
2016-02-26
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
FTLMesh, Surgical, Polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760193182118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760193182118037601931821183760193182118

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia surgical mesh, composite-polymerA flat or three-dimensional (3-D), woven/knitted material made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair/reinforcement applications; it is not intended for extra-abdominal applications and not dedicated to diaphragmatic hernia repair. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Centimeter
Width20Centimeter

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
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

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Primary DI, Brand, Company table
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09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222072OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
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09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
10884521857179ParieteneSOFRADIM PRODUCTIONFTL2025-11-08
08903837165978Surgical MeshHEALTHIUM MEDTECH LIMITEDFTL2023-08-31
09421906661552OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
09421906661569OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
10705031085978ULTRAPROJohnson & Johnson International Inc.FTL2022-11-08
10705031085985ULTRAPROJohnson & Johnson International Inc.FTL2022-11-08
10607567510996TigerPaw Pro Left Atrial Appendage Closure DeviceDATASCOPE CORP.FTL2020-11-18
09421905067539OviTex® LPRAROA BIOSURGERY LIMITEDFTL2020-03-13
10884521784086Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784093Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784109Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784123Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
09421906017052Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-29
09421905067157Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-14
09421905067645Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067690Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067706Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067713Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067720Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067751Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01