066.5003V4

GUDID 07630031779649

Straumann iGuide T-sleeve, Ø 5.2mm, stainless steel

Institut Straumann AG

Surgical drill guide, single-use
Primary Device ID07630031779649
NIH Device Record Keyfc9f3a3b-169f-4b8d-8b2e-a86bf0f4e335
Commercial Distribution StatusIn Commercial Distribution
Version Model Numbersurgically Invasive Instruments
Catalog Number066.5003V4
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count4
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com

Device Dimensions

Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031776365 [Primary]
GS107630031779649 [Unit of Use]

FDA Product Code

NDPAccessories, implant, dental, endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031779649]

Moist Heat or Steam Sterilization


[07630031779649]

Moist Heat or Steam Sterilization


[07630031779649]

Moist Heat or Steam Sterilization


[07630031779649]

Moist Heat or Steam Sterilization


[07630031779649]

Moist Heat or Steam Sterilization


[07630031779649]

Moist Heat or Steam Sterilization


[07630031779649]

Moist Heat or Steam Sterilization


[07630031779649]

Moist Heat or Steam Sterilization


[07630031779649]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-14
Device Publish Date2025-08-06

Devices Manufactured by Institut Straumann AG

07630031776334 - NA2025-08-14 Straumann iGuide Template Fixation Pin, Ø 1.5mm, TAN
07630031779632 - NA2025-08-14 Straumann iGuide T-Sleeve for Template Fixation Pin, Ø 1.5mm, stainless steel
07630031776358 - NA2025-08-14 Straumann iGuide Drill for Template Fixation Pin, Ø 1.5mm, stainless steel
07630031779649 - NA2025-08-14Straumann iGuide T-sleeve, Ø 5.2mm, stainless steel
07630031779649 - NA2025-08-14 Straumann iGuide T-sleeve, Ø 5.2mm, stainless steel
07630031776372 - NA2025-08-14 Straumann iGuide Mucosa Punch, for T-sleeve Ø 5.2mm, stainless steel
07630031776389 - NA2025-08-14 Straumann iGuide Milling Cutter Ø 5mm, for T-sleeve Ø 5.2mm, stainless steel
07630031776396 - NA2025-08-14 Straumann iGuide Drill Ø 2.2mm, L 6mm, for T-sleeve Ø 5.2mm, stainless steel
07630031776402 - NA2025-08-14 Straumann iGuide Drill Ø 2.2mm, L 8mm, for T-sleeve Ø 5.2mm, stainless steel

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