FDA.reportPublic FDA data

ETHILON

Primary DI
10705031030138
Brand
ETHILON
Company
ETHICON, LLC
Model
D8420
Catalog number
D8420
Device description
Ethilon Nylon Suture Black Monofilament, Sterile, Nonabsorbable Surgical Suture
Published
2015-09-23
Public version status
Update
Distribution status
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
GARSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, 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
30705031030132PackageGS112In Commercial Distribution
10705031030138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503103013230705031030132
1070503103013810705031030138

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. 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
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
10705031088054ETHILONETHICON, LLCGAR2026-07-03
10705031089600ETHILONETHICON, LLCGAR2026-07-03
10705031097018ETHILONETHICON, LLCGAR2026-07-03
10705031099975ETHILONETHICON, LLCGAR2026-07-03
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013068SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013280SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013563SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013587SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013600SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013877SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013952SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014041SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014096SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014188SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014362SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014393SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014560SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014713SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014744SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014768SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014911SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015048SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015093SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015147SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015253SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015277SUTUMEDUnilene S.A.C.GAR2023-01-06