FDA.reportPublic FDA data

STRATAFIX

Primary DI
30705031470068
Brand
STRATAFIX
Company
ETHICON, LLC
Model
SXMP1B444
Catalog number
SXMP1B444
Device description
Knotless Tissue Control Device, Dyed Unidirectional (Antibacterial) Synthetic Absorbable Device
Published
2023-07-06
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
GAMSuture, absorbable, synthetic, polyglycolic acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221744000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221744000STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.2022-11-15GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031470068PackageGS112In Commercial Distribution
10705031470064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503147006830705031470068
1070503147006410705031470064

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 Temperature030 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10705031023369PERMA-HANDC004DC004D2015-09-01
10705031023727NUROLONC503DC503D2015-09-01
10705031023741NUROLONC512DC512D2015-09-01
10705031023758NUROLONC513DC513D2015-09-01
10705031023765NUROLONC514DC514D2015-09-01
10705031023888NUROLONC553DC553D2015-09-01
10705031023895NUROLONC554DC554D2015-09-01
10705031023918NUROLONC563DC563D2015-09-01
10705031023987NUROLONC584DC584D2015-09-01
10705031024199ETHIBOND EXCELCX12DCX12D2015-09-01
10705031024205ETHIBOND EXCELCX13DCX13D2015-09-01
10705031088054ETHILON1628H1628H2026-07-03
10705031089600ETHILON648H648H2026-07-03
10705031097018ETHILONEH7553HEH7553H2026-07-03
10705031099975ETHILONFH5171HFH5171H2026-07-03
17891338994365VICRYL RAPIDEVR1626GVR1626G2026-07-03
17891338994389VICRYL RAPIDEVR1824HVR1824H2026-07-03
17891338994396VICRYL RAPIDEVR1828HVR1828H2026-07-03
17891338994440VICRYL RAPIDEVR1916GVR1916G2026-07-03
17891338994457VICRYL RAPIDEVR4890GVR4890G2026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052493SharpointSurgical Specialties México, S. de R.L. de C.V.GAM2026-07-06
00848782052509SharpointSurgical Specialties México, S. de R.L. de C.V.GAM2026-07-06
17891338994365VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994389VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994396VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994440VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994457VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994501VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994532VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994556VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994563VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994570VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994839VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994860VICRYL RAPIDEETHICON, LLCGAM2026-07-03
00840277412065ViletRIVERPOINT MEDICAL, LLCGAM2026-06-08
08904255257412PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257443PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257450PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257467PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257474PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257481PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255234369PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234376PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234383PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234390PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234406PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257306PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257313PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257320PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257337PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04