FDA.reportPublic FDA data

4DDOME®

Primary DI
03760185572927
Brand
4DDOME®
Company
COUSIN BIOTECH
Model
4DDOM24GSR
Device description
The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.
Published
2015-10-23
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0709180004DDOMECousin Biotech2007-08-22FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760185572927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760185572927037601855729273760185572927

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
Height15Millimeter
Outer Diameter24Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00To be stored in a dry place away from light, and at room temperature, in its original packaging

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33320144000contact@cousin-biotech.com
+33320144119f.pelletier@cousin-biotech.com

Regulatory Flags#

DUNS number
776742439
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760185576109ResCUBE™RCBCUBETUU2024-01-05
03760185570336Biomesh® CA.B.S.’Air® CompositeCABSAIRC092015-10-23
03760185570343Biomesh® CA.B.S.’Air® CompositeCABSAIRC72015-10-23
03760185570367BIOMESH®CA.B.S.'Air®CABSAIR062015-10-23
03760185570374Biomesh® CA.B.S.’Air® CompositeCABST1R05T2015-10-23
03760185570381BIOMESH®CA.B.S.'Air®CABS06P12015-10-23
037601855723234DDOME ®4DDOME24SR2015-10-23
037601855723474DDOME ®4DDOME30SR2015-10-23
037601855723614DDOME ®4DDOME38SR2015-10-23
037601855729344DDOME ®4DDOM30GSR2015-10-23
037601855729414DDOME ®4DDOM38GSR2015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06970461300244TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300251TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300268TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
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06970461300282TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300299TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300305TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22