Polysorb 170096

GUDID 10884521126831

Absorbable Single Stitch Reload

Covidien LP

Suture knot-tying device

• Primary Device ID: 10884521126831
• NIH Device Record Key: 1cf09328-bf57-4b01-9847-e740002e5f5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polysorb
• Version Model Number: 170096
• Catalog Number: 170096
• 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
• 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
• 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

Device Dimensions

• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch
• Device Size Text, specify: 0
• Length: 48 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521126831 [Package]; Contains: 20884521126838; Package: CASE [12 Units]; In Commercial Distribution
GS1	20884521126838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934738

FDA Product Code

• OCW: Endoscopic tissue approximation device

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Polysorb]

• 10884521049543: Braided Absorbable Suture
• 10884521048478: Braided Absorbable Suture
• 10884521042629: Braided Absorbable Suture
• 10884521176836: Meniscal Stapler Up Curved Loading Unit
• 10884521176829: Meniscal Stapler Straight Loading Unit
• 10884521126831: Absorbable Single Stitch Reload
• 10884521126824: Absorbable Single Stitch Reload
• 10884521126817: Absorbable Single Stitch Reload
• 10884521126800: Absorbable Single Stitch Reload
• 10884521126794: Absorbable Single Stitch Reload
• 10884521126787: Absorbable Single Stitch Reload
• 10884521126770: Absorbable Single Stitch Reload
• 10884521126763: Absorbable Single Stitch Reload
• 10884521126756: Absorbable Single Stitch Reload
• 10884521126749: Absorbable Single Stitch Reload
• 10884521126732: Absorbable Single Stitch Reload
• 10884521126619: Absorbable Single Stitch Reload
• 10884521126602: Absorbable Single Stitch Reload
• 10884521126596: Absorbable Single Stitch Reload
• 10884521126589: Absorbable Single Stitch Reload
• 10884521126572: Absorbable Single Stitch Reload
• 20884521133577: Braided Absorbable Suture
• 20884521130767: Braided Absorbable Suture
• 20884521130750: Braided Absorbable Suture
• 20884521130712: Braided Absorbable Suture
• 20884521130682: Braided Absorbable Suture
• 20884521130675: Braided Absorbable Suture
• 20884521046211: Braided Absorbable Suture
• 20884521045474: Braided Absorbable Suture
• 10884521181625: Bone Punch
• 10884521176966: Obturator
• 10884521176942: Twist Drill bit
• 10884521176935: Drill Bit
• 10884521176904: Drill Guide
• 20884521184050: Braided Absorbable Suture
• 20884521048840: Braided Absorbable Suture
• 20884521046952: Braided Absorbable Suture
• 20884521043760: Braided Absorbable Suture
• 20884521139555: Braided Absorbable Suture
• 20884521135137: Braided Absorbable Suture
• 20884521130781: Braided Absorbable Suture
• 20884521130743: Braided Absorbable Suture
• 20884521130606: Braided Absorbable Suture
• 20884521120157: Braided Absorbable Suture
• 20884521101743: Braided Absorbable Suture
• 20884521044255: Braided Absorbable Suture
• 20884521043562: Braided Absorbable Suture
• 20884521043517: Braided Absorbable Suture
• 20884521042725: Braided Absorbable Suture
• 20884521042664: Braided Absorbable Suture