FDA.reportPublic FDA data

STRATAFIX

Primary DI
30705031470020
Brand
STRATAFIX
Company
ETHICON, LLC
Model
SXMP1B453
Catalog number
SXMP1B453
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
30705031470020PackageGS112In Commercial Distribution
10705031470026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503147002030705031470020
1070503147002610705031470026

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
30705031242573Coated VICRYLJB947HJB947H2026-02-18
30705031242580Coated VICRYLJB977HJB977H2026-02-18
30705031054602VICRYLVCP644TVCP644T2026-02-09
30705031470624PDSPDP422ZHPDP422ZH2026-01-29
30705031045600PROLENEM821CM821C2026-01-07
30705031049097PRONOVAPN489GPN489G2026-01-07
30705031049103PRONOVAPN496GPN496G2026-01-07
30705031049172PRONOVAPN584GPN584G2026-01-07
30705031246175PRONOVAPN3558HPN3558H2026-01-07
30705031097234PROLENEEH7583HEH7583H2025-11-11
30705031098439PROLENEEH7835HEH7835H2025-11-11
30705031116201PROLENEF1880F18802025-11-11
30705031098477PROLENEEH7897GEH7897G2025-04-22
30705031228348PROLENEEP8729HEP8729H2025-04-22
30705031228621PROLENEEP8767HEP8767H2025-04-22
30705031237807PROLENEW753GW753G2025-04-22
30705031050864ETHICONTPW10TPW102015-09-24
10705031050877ETHICONTPW20TPW202015-09-01
10705031050884ETHICONTPW30TPW302015-09-01
10705031050891ETHICONTPW32TPW322015-09-01

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Primary DI, Brand, Company table
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00810126508232Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
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00810126508256Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
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