MONOCRYL MCP947H

GUDID 10705031046818

Antibacterial Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture

ETHICON, LLC

Polyester suture, bioabsorbable, monofilament, antimicrobial

• Primary Device ID: 10705031046818
• NIH Device Record Key: 11d8f069-8ab9-48b8-95b2-2de6b497c9c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONOCRYL
• Version Model Number: MCP947H
• Catalog Number: MCP947H
• 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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031046818 [Primary]
GS1	30705031046812 [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]

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• 10705031058743: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
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• 10705031058606: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031024403: Antibacterial Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
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• 10705031058583: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
• 10705031058576: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
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• 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