AnchorKnot Suture

GUDID 17540299000034

Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except for oversized diameter.

Baylis Medical Technologies Inc

Polyolefin suture, multifilament

• Primary Device ID: 17540299000034
• NIH Device Record Key: de1dbfc2-b0bd-4ae7-9c8f-e623e3bbd1a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnchorKnot Suture
• Version Model Number: ASU-2-0-WB-CL
• Company DUNS: 240389677
• Company Name: Baylis Medical Technologies Inc
• 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

Device Dimensions

• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
• Length: 30 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447000433 [Previous]
GS1	07540299000037 [Primary]
GS1	17540299000034 [Package]; Contains: 07540299000037; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151009

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2022-11-24
• Device Publish Date: 2022-11-16

On-Brand Devices [AnchorKnot Suture]

• 07540299000129: Reel, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized diamete
• 07540299000112: Reel, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except f
• 07540299000105: Cartridge, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized di
• 07540299000099: Cartridge, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP exc
• 07540299000082: Reel, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized diamete
• 07540299000075: Reel, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except f
• 17540299000065: Cut Length, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized d
• 17540299000058: Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP ex
• 17540299000041: Cut Length, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized d
• 17540299000034: Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP ex
• 17540299000027: Cut Length, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized d
• 07540299000013: Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP ex