PTFE Polymer Pledgets VPG56SE

GUDID 20884521550718

Nonabsorbable Pledgets, 10x Soft Pledgets 4.5x6x1.65mm

Covidien LP

Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: 20884521550718
• NIH Device Record Key: eda94147-97d6-4c69-9652-6aa385f8d170
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTFE Polymer Pledgets
• Version Model Number: VPG56SE
• Catalog Number: VPG56SE
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *None
• Special Storage Condition, Specify: Between 0 and 0 *None
• Special Storage Condition, Specify: Between 0 and 0 *None
• Special Storage Condition, Specify: Between 0 and 0 *None
• Special Storage Condition, Specify: Between 0 and 0 *None
• Special Storage Condition, Specify: Between 0 and 0 *None
• Special Storage Condition, Specify: Between 0 and 0 *None
• Special Storage Condition, Specify: Between 0 and 0 *None
• Special Storage Condition, Specify: Between 0 and 0 *None

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521550711 [Primary]
GS1	20884521550718 [Package]; Contains: 10884521550711; Package: PACK_OR_INNER_PACK [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930591

FDA Product Code

• GAT: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

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: 2017-06-28

On-Brand Devices [PTFE Polymer Pledgets]

• 20884521103174: Nonabsorbable Pre-punched Pledgets,5x Firm PTFE Pledgets 9.5x4.8x1.5mm
• 20884521550701: Nonabsorbable Pre-punched Pledgets, 10x Firm Pledgets 4.5x6x1.85mm
• 20884521104645: Nonabsorbable Pre-punched Pledgets,10x Soft PTFE Pledgets 3x7x1.5mm
• 20884521104638: Nonabsorbable Pre-punched Pledgets,5x Soft PTFE Pledgets 9.5x4.8x1.5mm
• 20884521104614: Nonabsorbable Pre-punched Pledgets,10x Firm PTFE Pledgets 3x7x1.5mm
• 20884521103181: Nonabsorbable Pre-punched Pledgets,10x Firm PTFE Pledgets 3x3x1.5mm
• 20884521550718: Nonabsorbable Pledgets, 10x Soft Pledgets 4.5x6x1.65mm
• 20884521550695: Nonabsorbable Pledgets, 10x Soft Pledgets 3x6x1.65mm
• 20884521550688: Nonabsorbable Pledgets, 10x Firm Pledgets 3x6x1.85mm