FDA.reportPublic FDA data

PRONOVA

Primary DI
10705031004641
Brand
PRONOVA
Company
ETHICON, LLC
Model
3709H
Catalog number
3709H
Device description
Blue Monofilament Poly(Hexafluoropropylene-VDF), Nonabsorbable Surgical Suture
Published
2015-09-01
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
GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001625000PRONOVA NONABSORBABLE SUTURE, USPETHICON, Inc.2000-07-10GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031004645PackageGS136In Commercial Distribution
10705031004641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503100464530705031004645
1070503100464110705031004641

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
829465157
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031051805Coated VICRYLVCP260HVCP260H2015-09-01
10705031051874Coated VICRYLVCP267HVCP267H2015-09-01
10705031051911Coated VICRYLVCP269HVCP269H2015-09-01
10705031053038Coated VICRYLVCP417HVCP417H2015-09-01
10705031055933Coated VICRYLVCP870HVCP870H2015-09-01
10705031056213Coated VICRYLVCP958HVCP958H2015-09-01
10705031056237Coated VICRYLVCP959HVCP959H2015-09-01
10705031051744Coated VICRYLVCP232HVCP232H2015-09-01
10705031052475Coated VICRYLVCP339HVCP339H2015-09-01
10705031052499Coated VICRYLVCP340HVCP340H2015-09-01
10705031052635Coated VICRYLVCP352HVCP352H2015-09-01
10705031053823Coated VICRYLVCP497HVCP497H2015-09-01
10705031056114Coated VICRYLVCP944HVCP944H2015-09-01
10705031056121Coated VICRYLVCP945HVCP945H2015-09-01
10705031056145Coated VICRYLVCP946HVCP946H2015-09-01
10705031053519Coated VICRYLVCP468HVCP468H2015-09-01
10705031097889ETHIBOND EXCELEH7755HEH7755H2026-07-17
10705031102996ETHIBOND EXCELPE6680HPE6680H2026-07-17
10705031103085ETHIBOND EXCELPE7055HPE7055H2026-07-17
10705031238404ETHIBOND EXCELW975GW975G2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837037824TruleneHEALTHIUM MEDTECH LIMITEDGAW2024-07-11
07757093024767SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024828SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024859SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024873SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025092SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025115SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025146SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025184SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025290SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025313SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025467SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025610SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025702SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025726SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025740SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025832SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026044SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026136SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026150SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026280SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026518SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093680543SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093023760SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023838SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023869SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023890SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023968SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024033SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024101SUTUMEDUnilene S.A.C.GAW2023-01-07