PROLENE D8229

GUDID 10705031029552

Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture

ETHICON, LLC

Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer 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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• 10705031032774: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
• 10705031032750: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
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