2c14 #2 Pdo 36 X 36

GUDID 10848782019523

2c14 #2 Pdo 36 X 36

Surgical Specialties México, S. de R.L. de C.V.

Polyester suture, bioabsorbable, monofilament

• Primary Device ID: 10848782019523
• NIH Device Record Key: 43c1b0e9-1e76-4382-b85e-5efb3e613eb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2c14 #2 Pdo 36 X 36
• Version Model Number: RX-1066Q
• Company DUNS: 812762226
• Company Name: Surgical Specialties México, S. de R.L. de C.V.
• Device Count: 1
• DM Exempt: true
• 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(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00848782019526 [Primary]
GS1	10848782019523 [Package]; Contains: 00848782019526; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120827

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: 2015-10-22

Devices Manufactured by Surgical Specialties México, S. de R.L. de C.V.

• 00848782051786 - Onatec: 2025-06-10 Onalon, Nylon, Black, 10-0, 10cm, DRS, 2 arms
• 00848782051793 - Onatec: 2025-06-10 Onalon, Nylon, Black, 10-0, 10cm, HLZ, 1 arm
• 00848782051809 - Onatec: 2025-06-10 Onalon, Nylon, Black, 10-0, 10cm, 1 arm
• 10848782051813 - Onatec: 2025-06-10 Onasorb,PGA,Violet,10-0,10cm,DLZ,1 arm
• 10848782051820 - Onatec: 2025-06-10 Onasorb,PGA,Violet,8-0,13cm,DDS,1 arm
• 10848782051837 - Onatec: 2025-06-10 Onasorb,PGA,Violet,8-0,13cm,DRS,1 arm
• 10848782051844 - Onatec: 2025-06-10 Onasorb,PGA,Violet,9-0,13cm,DDS,1 arm
• 10848782051851 - Onatec: 2025-06-10 Onasorb,PGA,Violet,9-0,13cm,DLZ,1 arm