PDM

GUDID 00812444020953

SUTURE

RIVERPOINT MEDICAL, LLC

Polyester suture, bioabsorbable, monofilament Polyester suture, bioabsorbable, monofilament 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 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 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: 00812444020953
• NIH Device Record Key: d5fd60e3-c144-431d-ac53-e51ea6050608
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PDM
• Version Model Number: D333
• Company DUNS: 964053560
• Company Name: RIVERPOINT MEDICAL, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812444020953 [Primary]
GS1	10812444020950 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100461

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: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-10-16

On-Brand Devices [PDM]

• 00812444021103: SUTURE
• 00812444021097: SUTURE
• 00812444021080: SUTURE
• 00812444021073: SUTURE
• 00812444021066: SUTURE
• 00812444021059: SUTURE
• 00812444021042: SUTURE
• 00812444021035: SUTURE
• 00812444021011: SUTURE
• 00812444021004: SUTURE
• 00812444020991: SUTURE
• 00812444020984: SUTURE
• 00812444020977: SUTURE
• 00812444020960: SUTURE
• 00812444020953: SUTURE
• 00812444020946: SUTURE
• 00812444020939: SUTURE
• 00812444020922: SUTURE
• 00812444020915: SUTURE
• 00812444020908: SUTURE
• 00812444020892: SUTURE
• 00812444020885: SUTURE
• 10812444029298: Suture
• 10812444021025: Suture
• 10810020084723: Suture
• 10810020084716: Suture
• 10810020084709: Suture
• 10810020084693: Suture