Straumann 4 mm Short Implants 033.044S

GUDID 07630031700841

Standard Plus Implant, Ø 4.8mm RN, SLActive® 4mm, Roxolid®, Loxim™

Institut Straumann AG

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• Primary Device ID: 07630031700841
• NIH Device Record Key: 60e9fdd1-fc5f-4176-9aab-3c2e48839732
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann 4 mm Short Implants
• Version Model Number: SLActive Roxolid TL
• Catalog Number: 033.044S
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 4 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031700841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202942

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [Straumann 4 mm Short Implants]

• 07630031714640: Standard Plus Implant, Ø 4.8mm WN, SLActive® 4mm, Roxolid®, Loxim™
• 07630031700841: Standard Plus Implant, Ø 4.8mm RN, SLActive® 4mm, Roxolid®, Loxim™
• 07630031700261: Standard Plus Implant, Ø 4.1mm RN, SLActive® 4mm, Roxolid®, Loxim™