Dermalon 88861742-21

GUDID 20884521070735

Monofilament Nylon,SCE-4,1x Blue Strand

Covidien LP

Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 20884521070735
• NIH Device Record Key: 79949aef-6808-4c2d-8aa0-f00b324cef9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermalon
• Version Model Number: 88861742-21
• Catalog Number: 88861742-21
• 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

Device Dimensions

• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521070738 [Primary]
GS1	20884521070735 [Package]; Contains: 10884521070738; Package: CASE [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981582

FDA Product Code

• GAR: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

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: 2015-08-30

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• 20884521071046: Monofilament Nylon
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• 20884521071008: Monofilament Nylon
• 20884521070988: Monofilament Nylon
• 20884521070940: Monofilament Nylon
• 20884521070926: Monofilament Nylon
• 20884521070919: Monofilament Nylon
• 20884521070902: Monofilament Nylon
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• 20884521070797: Monofilament Nylon
• 20884521070780: Monofilament Nylon
• 20884521070766: Monofilament Nylon
• 20884521070759: Monofilament Nylon
• 20884521070742: Monofilament Nylon
• 20884521070735: Monofilament Nylon,SCE-4,1x Blue Strand
• 20884521070728: Monofilament Nylon
• 20884521070711: Monofilament Nylon
• 20884521070698: Monofilament Nylon
• 20884521070681: Monofilament Nylon
• 20884521070667: Monofilament Nylon
• 20884521070650: Monofilament Nylon