FDA.reportPublic FDA data

STRATAFIX

Primary DI
10705031464346
Brand
STRATAFIX
Company
ETHICON, LLC
Model
SXMP2B405
Catalog number
SXMP2B405
Device description
Stratafix (Spiral MONOCRYL Plus), Bidirectional
Published
2023-03-24
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
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
K192580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192580000STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.2019-12-18GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031464340PackageGS112In Commercial Distribution
10705031464346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503146434030705031464340
1070503146434610705031464346

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
10705031064669MERSILENEF1506F15062026-08-25
10705031064683MERSILENEF1532F15322026-08-25
10705031064706MERSILENEF1534F15342026-08-25
10705031064805MERSILENEF2502F25022026-08-25
10705031064812MERSILENEF2503F25032026-08-25
10705031064904MERSILENEF2515F25152026-08-25
10705031064959MERSILENEF2520F25202026-08-25
10705031064973MERSILENEF2525F25252026-08-25
10705031065185MERSILENEF2570F25702026-08-25
10705031065369MERSILENEFR832FR8322026-08-25
10705031089020ETHILON2871G2871G2026-08-25
10705031096479ETHILONEH7436GEH7436G2026-08-25
10705031097421MERSILENEEH7638HEH7638H2026-08-25
10705031097599MERSILENEEH7684HEH7684H2026-08-25
10705031097865MERSILENEEH7750HEH7750H2026-08-25
10705031241060MERSILENEF1533HF1533H2026-08-25
10705031241077MERSILENEF2506HF2506H2026-08-25
10705031241107MERSILENEF2514HF2514H2026-08-25
10705031241114MERSILENEF2516HF2516H2026-08-25
10705031241138MERSILENEF2520HF2520H2026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10884521839861TrexonCovidien LPGAM2026-10-10
10884521840089TrexonCovidien LPGAM2026-10-10
10884521840126TrexonCovidien LPGAM2026-10-10
10884521840140TrexonCovidien LPGAM2026-10-10
10884521840171TrexonCovidien LPGAM2026-10-10
10884521840195TrexonCovidien LPGAM2026-10-10
10884521840249TrexonCovidien LPGAM2026-10-10
10884521840263TrexonCovidien LPGAM2026-10-10
10884521840270TrexonCovidien LPGAM2026-10-10
10884521840379TrexonCovidien LPGAM2026-10-10
10884521840409TrexonCovidien LPGAM2026-10-10
10884521840430TrexonCovidien LPGAM2026-10-10
10884521840447TrexonCovidien LPGAM2026-10-10
10884521840454TrexonCovidien LPGAM2026-10-10
10884521840461TrexonCovidien LPGAM2026-10-10
10884521840478TrexonCovidien LPGAM2026-10-10
10884521840485TrexonCovidien LPGAM2026-10-10
10884521840492TrexonCovidien LPGAM2026-10-10
10884521840508TrexonCovidien LPGAM2026-10-10
10884521840591TrexonCovidien LPGAM2026-10-10
10884521840614TrexonCovidien LPGAM2026-10-10
10884521840645TrexonCovidien LPGAM2026-10-10
10884521840652TrexonCovidien LPGAM2026-10-10
10884521840669TrexonCovidien LPGAM2026-10-10
10884521840676TrexonCovidien LPGAM2026-10-10
10884521840683TrexonCovidien LPGAM2026-10-10
10884521840690TrexonCovidien LPGAM2026-10-10
10884521840706TrexonCovidien LPGAM2026-10-10
10884521840720TrexonCovidien LPGAM2026-10-10