FDA.reportPublic FDA data

Enduragen

Primary DI
10884521190689
Brand
Enduragen
Company
SOFRADIM PRODUCTION
Model
89221
Device description
Collagen Implant
Published
2015-10-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013625000PERMACOLTissue Science Laboratories, Plc2002-01-17FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521190689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452119068910884521190689

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobialA bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Length0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
576342646
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884521176420ParietexPNP6X32015-10-22
20884521176437ParietexPNP8X32015-10-22
10884521178465ParietexPCO2H32015-10-06
10884521179660ParietexPCO3728FX2015-10-12
10884521553521Parietene DSPPDS12X32017-12-15
10884521553538Parietene DSPPDS1510X32017-12-15
10884521553545Parietene DSPPDS15X32017-12-15
10884521553552Parietene DSPPDS2015X32017-12-15
10884521784086Parietene DSPPDS12X32020-01-26
10884521784093Parietene DSPPDS1510X32020-01-26
10884521784109Parietene DSPPDS15X32020-01-26
10884521784123Parietene DSPPDS2015X32020-01-26
10884523000023PermacolP0502052015-10-22
10884523000085PermacolP1003082015-10-16
10884521532298VersatexVTX5050M2016-04-15
10884521178472ParietexPCO2H42015-10-06
20884521176444ParietexPNP62015-10-06
20884521176451ParietexPNP82015-10-06
10884521190412SymbotexSYM1710E2015-10-06
10884521190474SymbotexSYM2515E2015-10-06

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Primary DI, Brand, Company table
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