PDS ZK10G

GUDID 20705031206486

PDS II VLT 0 107CM AG ST3

ETHICON INC.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 20705031206486
• NIH Device Record Key: e46a9497-3f44-4ad0-8c16-b23d7eb0f1bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PDS
• Version Model Number: ZK10G
• Catalog Number: ZK10G
• Company DUNS: 002144145
• Company Name: ETHICON 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031206489 [Primary]
GS1	20705031206486 [Package]; Contains: 10705031206489; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: N18331

FDA Product Code

• NEW: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-09-24

On-Brand Devices [PDS]

• 10705031134348: Antibacterial Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
• 30705031231027: Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
• 20705031206486: PDS II VLT 0 107CM AG ST3
• 10705031048614: Antibacterial Clear Monofilament (Polydioxanone), Absorbable Surgical Suture
• 10705031048423: Antibacterial Clear Monofilament (Polydioxanone), Absorbable Surgical Suture
• 10705031048294: Antibacterial Clear Monofilament (Polydioxanone), Absorbable Surgical Suture
• 30705031030095: Violet Monofilament (Polydioxanone), Absorbable Surgical Suture