FDA.reportPublic FDA data

STRATAFIX

Primary DI
10705031472761
Brand
STRATAFIX
Company
ETHICON, LLC
Model
SXPN1B404
Catalog number
SXPN1B404
Device description
Knotless Tissue Control Device, Dyed Monofilament Synthetic Non-Absorbable Device
Published
2026-10-29
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
GAWSuture, nonabsorbable, synthetic, polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253572000STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.2026-03-27GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031472765PackageGS112In Commercial Distribution
10705031472761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503147276530705031472765
1070503147276110705031472761

GMDN Terms#

Term, Definition table
TermDefinition
Barbed polyolefin/fluoropolymer sutureA single-strand (monofilament), synthetic, non-bioabsorbable thread made from a polyolefin (e.g., polypropylene) or fluoropolymer (e.g., polyvinylidene fluoride) 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) to eliminate the need to tie a knot, and may include disposable suture application devices. It provides temporary wound support until the wound heals to withstand normal stress, after which it may be removed. It does not include antimicrobial materials. 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
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
10705031472754STRATAFIXSXPN1B402SXPN1B4022026-10-29
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
10705031064669MERSILENEF1506F15062026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031472754STRATAFIXETHICON, LLCGAW2026-10-29
10705031472778STRATAFIXETHICON, LLCGAW2026-10-29
10705031472785STRATAFIXETHICON, LLCGAW2026-10-29
10705031472792STRATAFIXETHICON, LLCGAW2026-10-29
10705031472808STRATAFIXETHICON, LLCGAW2026-10-29
10705031472815STRATAFIXETHICON, LLCGAW2026-10-29
10705031472822STRATAFIXETHICON, LLCGAW2026-10-29
10705031472839STRATAFIXETHICON, LLCGAW2026-10-29
10705031472846STRATAFIXETHICON, LLCGAW2026-10-29
10705031472853STRATAFIXETHICON, LLCGAW2026-10-29
10705031472860STRATAFIXETHICON, LLCGAW2026-10-29
10705031472877STRATAFIXETHICON, LLCGAW2026-10-29
10705031472884STRATAFIXETHICON, LLCGAW2026-10-29
10705031472891STRATAFIXETHICON, LLCGAW2026-10-29
10705031472907STRATAFIXETHICON, LLCGAW2026-10-29
10705031472914STRATAFIXETHICON, LLCGAW2026-10-29
10705031472921STRATAFIXETHICON, LLCGAW2026-10-29
10705031472938STRATAFIXETHICON, LLCGAW2026-10-29
10705031472945STRATAFIXETHICON, LLCGAW2026-10-29
08903837224514TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224538TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224552TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837337238TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
10705031091412PROLENEETHICON, LLCGAW2026-08-17
10705031091467PROLENEETHICON, LLCGAW2026-08-17
10705031091474PROLENEETHICON, LLCGAW2026-08-17
10705031091764PROLENEETHICON, LLCGAW2026-08-17
10705031095045PROLENEETHICON, LLCGAW2026-08-17
10705031095359PROLENEETHICON, LLCGAW2026-08-17
10705031096325PROLENEETHICON, LLCGAW2026-08-17