PDS PDP441H

GUDID 10705031048294

Antibacterial Clear Monofilament (Polydioxanone), Absorbable Surgical Suture

ETHICON INC.

Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial

• Primary Device ID: 10705031048294
• NIH Device Record Key: 32bc373c-6dbe-41ee-a067-e4ed19f1c32a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PDS
• Version Model Number: PDP441H
• Catalog Number: PDP441H
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031048294 [Primary]
GS1	30705031048298 [Package]; Package: BOX [36 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: 2021-02-05
• Device Publish Date: 2015-09-01

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• 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