FDA.reportPublic FDA data

STRATAFIX

Primary DI
10705031245242
Brand
STRATAFIX
Company
ETHICON, LLC
Model
SXPP1A436
Catalog number
SXPP1A436
Device description
Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
Published
2018-01-26
Public version status
Update
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
NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEWSuture, Surgical, Absorbable, PolydioxanoneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031245246PackageGS112In Commercial Distribution
10705031245242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503124524630705031245246
1070503124524210705031245242

GMDN Terms#

Term, Definition table
TermDefinition
Barbed polyester suture, antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester, and containing an agent to locally inhibit bacterial growth, intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is absorbed by hydrolysis. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
079402290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809963474109MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963474116MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963474123MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963478428MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963478435MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963478459MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
18800145524299Miracu FCL LSCO 19Gx45mmFeeltech Co.,Ltd.NEW2026-08-25
18800145525913JBP V Line Edge 19Gx45mmFeeltech Co.,Ltd.NEW2026-08-25
18800145525920JBP V Line Force 19Gx70mmFeeltech Co.,Ltd.NEW2026-08-25
08809963477384MINTHans Biomed Corp.NEW2026-07-28
08809963477445MINTHans Biomed Corp.NEW2026-07-28
08809963477858MINTHans Biomed Corp.NEW2026-07-28
08904255243903PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255244009PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255244016PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255247628PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255247697PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255250536PINION™ PDO Knotless SutureThe PINION™ PDO Knotless Suture consists of barbed suMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255250925PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255251021PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255251168PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252141PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252158PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252301PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252318PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252332PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252349PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252370PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252820PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255253049PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05