Straumann PrefGel 075.203W

GUDID 07630031730053

Straumann® PrefGel®, 5 x 0.6 ml (24% EDTA)

Institut Straumann AG

Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner Dental root surface conditioner

• Primary Device ID: 07630031730053
• NIH Device Record Key: 22a296bf-e892-4246-96ef-8daa4178d9a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann PrefGel
• Version Model Number: PrefGel
• Catalog Number: 075.203W
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• 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: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031730053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063812

FDA Product Code

• KJJ: CLEANSER, ROOT CANAL

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: 2023-10-09
• Device Publish Date: 2023-09-30

Devices Manufactured by Institut Straumann AG

• 07630031772534 - NA: 2024-06-13 TLX SP Guided Implant Driver, for adapter, H4 stop, stainless steel
• 07630031772541 - NA: 2024-06-13 TLX S Guided Implant Driver, for adapter, H4 stop, stainless steel
• 07630031772671 - NA: 2024-06-13 BLX Guided Implant Driver, for adapter, H4 stop, stainless steel
• 07630031764713 - Straumann® BLC and TLC Implants - Line extension: 2024-05-13 BLC Implant, Ø 6.5mm WB, SLActive 16mm, Roxolid
• 07630031765710 - Straumann® BLC and TLC Implants - Line extension: 2024-05-13 TLC S Implant, Ø 5.5mm WT, SLActive 14mm, Roxolid
• 07630031765727 - Straumann® BLC and TLC Implants - Line extension: 2024-05-13 TLC S Implant, Ø 5.5mm WT, SLActive 16mm, Roxolid
• 07630031765741 - Straumann® BLC and TLC Implants - Line extension: 2024-05-13 TLC S Implant, Ø 6.5mm WT, SLActive 8mm, Roxolid
• 07630031765758 - Straumann® BLC and TLC Implants - Line extension: 2024-05-13 TLC S Implant, Ø 6.5mm WT, SLActive 10mm, Roxolid