MONOCRYL MCPB316H

GUDID 10705031046849

Antibacterial Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture

ETHICON, LLC

Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial

• Primary Device ID: 10705031046849
• NIH Device Record Key: 64d1b6e2-c5ef-4daa-995e-6844408eb47f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONOCRYL
• Version Model Number: MCPB316H
• Catalog Number: MCPB316H
• Company DUNS: 079402290
• Company Name: ETHICON, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031046849 [Primary]
GS1	30705031046843 [Package]; Package: BOX [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050845

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-12-04
• Device Publish Date: 2015-09-01

On-Brand Devices [MONOCRYL]

• 10705031464865: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059351: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059313: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059306: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059276: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059177: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059146: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059139: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059108: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059085: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059061: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058866: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058835: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058767: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058743: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058712: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059191: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058873: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058606: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031024403: Antibacterial Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058675: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058583: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058576: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058569: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 30705031245406: Undyed Monofilament (Poliglecaprone 25), Synthetic Absorbable Surgical Suture
• 10705031059337: Undyed Monofilament (Poliglecaprone 25), Synthetic Absorbable Surgical Suture
• 30705031034697: Undyed Monofilament (Poliglecaprone 25), Synthetic Absorbable Surgical Suture
• 10705031060098: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031060081: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031060074: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031060067: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059917: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059887: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059856: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059818: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059801: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059795: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059672: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059658: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059498: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059412: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031059375: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031227613: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031218642: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031218635: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031218628: Antibacterial Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031218611: Antibacterial Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031218604: Antibacterial Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031134362: Antibacterial Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031060142: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture