PDS D10059

GUDID 10705031134348

Antibacterial Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture

ETHICON INC.

Polyester suture, bioabsorbable, monofilament, antimicrobial

• Primary Device ID: 10705031134348
• NIH Device Record Key: 79ce2a59-c624-4697-b0ba-1c94d34346c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PDS
• Version Model Number: D10059
• Catalog Number: D10059
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031134348 [Primary]
GS1	30705031134342 [Package]; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061037

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: 5
• Public Version Date: 2020-02-20
• Device Publish Date: 2015-09-01

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