2t9 -0- Undyed Monoderm 36x36

GUDID 10848782021991

2t9 -0- Undyed Monoderm 36x36

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

Poliglecaprone suture

• Primary Device ID: 10848782021991
• NIH Device Record Key: c468ed70-90a5-4c7f-beb1-bc0f7ef2d68f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2t9 -0- Undyed Monoderm 36x36
• Version Model Number: YA-1029Q
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848782021994 [Primary]
GS1	10848782021991 [Package]; Contains: 00848782021994; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072028

FDA Product Code

• GAM: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

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: 2015-10-22

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