FDA.reportPublic FDA data

ETHICON

Primary DI
10705031045361
Brand
ETHICON
Company
ETHICON, LLC
Model
M435G
Catalog number
M435G
Device description
Monofilament 316L Stainless Steel, 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
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
30705031045365PackageGS112In Commercial Distribution
10705031045361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503104536530705031045365
1070503104536110705031045361

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
10705031472754STRATAFIXSXPN1B402SXPN1B4022026-10-29
10705031472761STRATAFIXSXPN1B404SXPN1B4042026-10-29
10705031472778STRATAFIXSXPN1B409SXPN1B4092026-10-29
10705031472785STRATAFIXSXPN1B411SXPN1B4112026-10-29
10705031472792STRATAFIXSXPN1B413SXPN1B4132026-10-29
10705031472808STRATAFIXSXPN2B400SXPN2B4002026-10-29
10705031472815STRATAFIXSXPN1B400SXPN1B4002026-10-29
10705031472822STRATAFIXSXPN1B403SXPN1B4032026-10-29
10705031472839STRATAFIXSXPN1B412SXPN1B4122026-10-29
10705031472846STRATAFIXSXPN1B401SXPN1B4012026-10-29
10705031472853STRATAFIXSXPN1B410SXPN1B4102026-10-29
10705031472860STRATAFIXSXPN1B408SXPN1B4082026-10-29
10705031472877STRATAFIXSXPN2B402SXPN2B4022026-10-29
10705031472884STRATAFIXSXPN1B405SXPN1B4052026-10-29
10705031472891STRATAFIXSXPN1B406SXPN1B4062026-10-29
10705031472907STRATAFIXSXPN1B407SXPN1B4072026-10-29
10705031472914STRATAFIXSXPN2B403SXPN2B4032026-10-29
10705031472921STRATAFIXSXPN2B404SXPN2B4042026-10-29
10705031472938STRATAFIXSXPN2B405SXPN2B4052026-10-29
10705031472945STRATAFIXSXPN2B406SXPN2B4062026-10-29

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