FDA.reportPublic FDA data

ETHICON

Primary DI
10705031238749
Brand
ETHICON
Company
ETHICON, LLC
Model
D10192
Catalog number
D10192
Device description
Monofilament 316L Stainless Steel, Nonabsorbable Surgical Suture
Published
2016-04-27
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
GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170767000
K946173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170767000Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.2017-11-01GAQ
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
30705031238743PackageGS112In Commercial Distribution
10705031238749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503123874330705031238743
1070503123874910705031238749

GMDN Terms#

Term, Definition table
TermDefinition
Metallic suture, monofilamentA single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079402290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031001435ETHILON1629H1629H2015-09-01
10705031006393ETHILON585H585H2015-09-01
10705031007703ETHILON661H661H2015-09-01
10705031007789ETHILON663H663H2015-09-01
10705031007918ETHILON669H669H2015-09-01
10705031008724PERMA-HAND706G706G2015-09-01
10705031129931ETHICONW945W9452026-05-18
10705031239777ETHIBOND EXCELX4B37GX4B37G2018-01-25
10705031239784ETHIBOND EXCELX4B77GX4B77G2018-01-31
10705031462144ETHIBOND EXCEL10X52N10X52N2019-07-04
10705031462168ETHIBOND EXCEL10X72N10X72N2019-07-04
10705031462175ETHIBOND EXCEL10X66N10X66N2019-07-04
10705031468214ETHIBOND EXCELD7576ND7576N2021-05-08
10705031468221ETHIBOND EXCELD10048ND10048N2021-05-08
10705031468238ETHIBOND EXCELD7581ND7581N2021-05-08
10705031468245ETHIBOND EXCELD7924ND7924N2021-05-08
10705031468276ETHIBOND EXCELD8492ND8492N2021-05-08
10705031468320ETHIBOND EXCELD9079ND9079N2021-05-08
10705031468344ETHIBOND EXCELD9329ND9329N2021-05-08
10705031468351ETHIBOND EXCELD9607ND9607N2021-05-08

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