FDA.reportPublic FDA data

MERSILENE

Primary DI
10705031097414
Brand
MERSILENE
Company
ETHICON, LLC
Model
EH7637H
Catalog number
EH7637H
Device description
Green Dyed Multifilament Synthetic Nonabsorbable Suture
Published
2026-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K946173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946173000STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKETHICON, Inc.1995-01-09GAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031097418PackageGS136In Commercial Distribution
10705031097414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503109741830705031097418
1070503109741410705031097414

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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.

Contacts#

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

Regulatory Flags#

DUNS number
829465157
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
10705031471863VICRYLVCP1828HVCP1828H2026-08-19
10705031472150Coated VICRYLVCP776DVCP776D2026-08-19
10705031472167Coated VICRYLJ4751GJ4751G2026-08-19
10705031472211VICRYLJ1744GJ1744G2026-08-19
10705031472228VICRYLJ1735GJ1735G2026-08-19
10705031005730PERMA-HAND482T482T2015-09-01
10705031010468ETHILON7707G7707G2015-09-01
10705031010482ETHILON7711G7711G2015-09-01
10705031022461ETHILON9030G9030G2015-09-01
10705031022515ETHILON9033G9033G2015-09-01
10705031027077PROLENED7007D70072015-09-01
10705031030893PROLENED8679D86792015-09-01
10705031031968PROLENED9068D90682015-09-01
10705031032972PROLENED9399D93992015-09-01
10705031033061PROLENED9425D94252015-09-01
10705031026926ETHILOND6906D69062015-09-01
10705031244955STRATAFIXSXPP1A431SXPP1A4312018-01-26
10705031244986STRATAFIXSXPP1A415SXPP1A4152018-01-26
10705031245013STRATAFIXSXPP1A429SXPP1A4292018-01-26
10705031245020STRATAFIXSXPP1A428SXPP1A4282018-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860424000273SpeedGraft QuadLink TendonJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000280PilotGraft BTB Tendon, 9 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000297PilotGraft BTB Tendon, 11 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00191083047676RapidEase™Rti Surgical, Inc.GAT2023-11-03
00191083047683RapidEase™Rti Surgical, Inc.GAT2023-11-03
00860424000266SpeedGraft Achilles TendonJOINT RESTORATION FOUNDATION INCGAT2022-08-31
00860424000259JRF PilotGraft BTBJOINT RESTORATION FOUNDATION INCGAT2021-04-02
00860424000242JRF VersaGraft 3.5JOINT RESTORATION FOUNDATION INCGAT2018-09-18
14026704426260DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
14026704427250DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
00860424000235JRF GraftLink XLJOINT RESTORATION FOUNDATION INCGAT2016-03-30
00889858118491FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117111FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117135FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117159FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117173FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117210FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117234FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117258FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117296FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117333FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117357FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117371FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117432FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117456FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117494FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117517FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117555FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117579FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117616FlexiGRAFT®LIFENET HEALTHGAT2015-09-24