FDA.reportPublic FDA data

ETHILON

Primary DI
10705031465374
Brand
ETHILON
Company
ETHICON, LLC
Model
GW1685H
Catalog number
GW1685H
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
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
30705031465378PackageGS136In Commercial Distribution
10705031465374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503146537830705031465378
1070503146537410705031465374

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
10705031064669MERSILENEF1506F15062026-08-25
10705031064683MERSILENEF1532F15322026-08-25
10705031064706MERSILENEF1534F15342026-08-25
10705031064805MERSILENEF2502F25022026-08-25
10705031064812MERSILENEF2503F25032026-08-25
10705031064904MERSILENEF2515F25152026-08-25
10705031064959MERSILENEF2520F25202026-08-25
10705031064973MERSILENEF2525F25252026-08-25
10705031065185MERSILENEF2570F25702026-08-25
10705031065369MERSILENEFR832FR8322026-08-25
10705031089020ETHILON2871G2871G2026-08-25
10705031096479ETHILONEH7436GEH7436G2026-08-25
10705031097421MERSILENEEH7638HEH7638H2026-08-25
10705031097599MERSILENEEH7684HEH7684H2026-08-25
10705031097865MERSILENEEH7750HEH7750H2026-08-25
10705031241060MERSILENEF1533HF1533H2026-08-25
10705031241077MERSILENEF2506HF2506H2026-08-25
10705031241107MERSILENEF2514HF2514H2026-08-25
10705031241114MERSILENEF2516HF2516H2026-08-25
10705031241138MERSILENEF2520HF2520H2026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052516SharpointSurgical Specialties México, S. de R.L. de C.V.GAR2026-08-26
10705031089020ETHILONETHICON, LLCGAR2026-08-25
10705031096479ETHILONETHICON, LLCGAR2026-08-25
00816848022964SUPRAMIDS JACKSON INCGAR2026-08-21
00816848022988SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023008SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023329SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023343SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023367SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023381SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023527SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023541SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023664SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023688SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023787SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023800SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023824SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023848SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023862SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023886SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023947SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023954SUPRAMIDS JACKSON INCGAR2026-08-21
00816848024029SUPRAMIDS JACKSON INCGAR2026-08-21
08903837402325TrulonHEALTHIUM MEDTECH LIMITEDGAR2026-08-19
08903837799326TrulonHEALTHIUM MEDTECH LIMITEDGAR2026-08-19
10705031245587ETHILONETHICON, LLCGAR2026-08-17
10705031245624ETHILONETHICON, LLCGAR2026-08-17
10705031465381ETHILONETHICON, LLCGAR2026-08-17
10705031465404ETHILONETHICON, LLCGAR2026-08-17
10705031470651ETHILONETHICON, LLCGAR2026-08-17