STRATAFIX SXMP2B415

GUDID 20705031465234

Stratafix (Spiral MONOCRYL Plus), Bidirectional

ETHICON, LLC

Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial Barbed polyester suture, antimicrobial

• Primary Device ID: 20705031465234
• NIH Device Record Key: c6edce2c-3acf-4968-a2a3-ff673a6d8a67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRATAFIX
• Version Model Number: SXMP2B415
• Catalog Number: SXMP2B415
• Company DUNS: 829465157
• Company Name: ETHICON, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031465237 [Primary]
GS1	20705031465234 [Package]; Contains: 10705031465237; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192580

FDA Product Code

• GAM: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-03
• Device Publish Date: 2023-03-24

On-Brand Devices [STRATAFIX]

• 30705031236718: Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Devic
• 30705031236411: Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Devic
• 30705031236343: Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Devic
• 30705031236329: Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Devic
• 30705031245390: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245383: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245372: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245369: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245352: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245341: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245334: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245327: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245314: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245303: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245297: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245280: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245273: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245260: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245259: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245242: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245239: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245222: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245215: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245204: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245192: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245185: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245178: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245167: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245154: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245147: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245136: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245129: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245112: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245109: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245093: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245086: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245075: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245062: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245055: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245044: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245031: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245024: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031245017: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031245006: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031244993: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031244980: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031244979: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031244962: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 30705031244959: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
• 10705031227743: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device