037.3006

GUDID 07630031772534

TLX SP Guided Implant Driver, for adapter, H4 stop, stainless steel

Institut Straumann AG

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• Primary Device ID: 07630031772534
• NIH Device Record Key: e4a11c0c-c6bd-4c6e-9f61-1ac78c64e439
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: surgically Invasive Instruments
• Catalog Number: 037.3006
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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
• 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

• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031772534 [Primary]

FDA Product Code

• NDP: Accessories, implant, dental, endosseous

Sterilization

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

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

[07630031772534]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-13
• Device Publish Date: 2024-06-05

Devices Manufactured by Institut Straumann AG

• 07630031772534 - NA: 2024-06-13TLX SP Guided Implant Driver, for adapter, H4 stop, stainless steel
• 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