PROLENE D8229

GUDID 10705031029552

Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture

ETHICON, LLC

Polyolefin suture, monofilament

• Primary Device ID: 10705031029552
• NIH Device Record Key: 87ba3566-9d1e-4bc3-9213-ceb95a187599
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROLENE
• Version Model Number: D8229
• Catalog Number: D8229
• 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: false
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031029552 [Primary]
GS1	30705031029556 [Package]; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133356

FDA Product Code

• GAW: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-25
• Device Publish Date: 2015-09-01

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• 20705031050461: Soft Polypropylene Mesh, Nonabsorbable Synthetic Surgical Mesh
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• 10705031035546: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031035409: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031035140: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
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• 10705031034754: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031034747: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031034006: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031033993: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031033061: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031033047: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031032781: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031032774: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031032750: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031032378: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031031982: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031031944: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
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• 10705031030190: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture