GUIDOR 5050

GUDID 00070942000062

GUIDOR® Bioresorbable Matrix Barrier

SUNSTAR AMERICAS, INC.

Pliable-polymer dental regeneration membrane, bioabsorbable, ligated

• Primary Device ID: 00070942000062
• NIH Device Record Key: 7ca0f5f2-9cc7-4bdd-b27d-c8a340469e91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUIDOR
• Version Model Number: PPS-R
• Catalog Number: 5050
• Company DUNS: 025066358
• Company Name: SUNSTAR AMERICAS, INC.
• 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: true
• 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: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
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• Phone: 8774843671
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• Phone: 8774843671
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• Phone: 8774843671
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• Phone: 8774843671
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• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
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• Phone: 8774843671
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• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
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• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx
• Phone: 8774843671
• Email: xx@xx.xx

Device Dimensions

• Length: 10 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
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• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Length: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter
• Height: 12.7 Millimeter
• Width: 10 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Allow GUIDOR Matrix Barrier to reach room temperature prior to use

Device Identifiers

Device Issuing Agency	Device ID
GS1	00070942000062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132325

FDA Product Code

• NPK: Barrier, Synthetic, Intraoral

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: 2015-10-14

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• 00070942000048: GUIDOR® Bioresorbable Matrix Barrier
• 00070942000031: GUIDOR® Bioresorbable Matrix Barrier
• 00070942000017: GUIDOR® Bioresorbable Matrix Barrier
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• 17640164360130: Bone grafting material, synthetic
• 17640164360123: Bone grafting material, synthetic
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