FDA.reportPublic FDA data

NA

Primary DI
07630031778086
Brand
NA
Company
Institut Straumann AG
Model
surgically Invasive Instruments
Catalog number
066.5063
Device description
Straumann iGuide T-sleeve, Ø 3.9 mm, stainless steel
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031778086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031778086076300317780867630031778086

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031736451Straumann BoneceramicBoneCeramic070.1982022-04-01
07630031736468Straumann BoneceramicBoneCeramic070.1992022-04-01
07630031736475Straumann BoneceramicBoneCeramic070.2002022-04-01
07630031700155STRAUMANN GRANULESBoneCeramic070.2032015-09-24
07630031700162STRAUMANN GRANULESBoneCeramic070.2042015-09-24
07630031700179STRAUMANN GRANULESBoneCeramic070.2052015-09-24
07630031739575NAAnatomic drill guides010.40212022-11-10
07630031755537CoDiagnostiXAnatomic drill guides010.40302022-04-29
07630031739933Surgical Guide - 3D Printed Model2017010.40212018-07-19
07630031764263Straumann® BLC Implants - Indication WideningSLA Roxolid BL035.8218S2023-11-04
07630031764331Straumann® BLC Implants - Indication WideningSLActive Roxolid BL035.9218S2023-11-04
07630031778093NAsurgically Invasive Instruments066.50642026-06-03
07630031778109NAsurgically Invasive Instruments066.50652026-06-03
07630031778116NAsurgically Invasive Instruments066.50662026-06-03
07630031778123NAsurgically Invasive Instruments066.50672026-06-03
07630031778130NAsurgically Invasive Instruments066.50682026-06-03
07630031778147NAsurgically Invasive Instruments066.50692026-06-03
07630031778154NAsurgically Invasive Instruments066.50702026-06-03
07630031778161NAsurgically Invasive Instruments066.50712026-06-03
07630031778192NAsurgically Invasive Instruments066.50742026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995226457SLEEVE FOR SURGICAL GUIDEØ5.1MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226464SLEEVE FOR SURGICAL GUIDE Ø5.1MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226471SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226488SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226495SLEEVE FOR SURGICAL GUIDE Ø5.1MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226501SLEEVE FOR SURGICAL GUIDE Ø5.1MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226518SLEEVE FOR SURGICAL GUIDE Ø3.9MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226525SLEEVE FOR SURGICAL GUIDE Ø3.9MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226532SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226556SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226563SLEEVE FOR FIXER GUIDE Ø1.4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234346DRIVER RATCHET IMP. MT16° GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234353DRIVER RATCHET IMP. MT16° GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234360DRIVER HANDP. IMP. MT16° GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234377DRIVER HANDP. IMP. MT16° GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234391ANALOG REVERSE MICRO MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234407ANALOG REVERSE MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234414ANALOG REVERSE CM11.5°Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234421ANALOG REVERSE MT16°Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234438ANALOG REVERSE ABUT MULT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234445ANALOG HYBRIDO ABUT UNIV Ø4.5X6MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234452ANALOG HYBRIDO ABUT UNIV Ø4.5X4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234469ANALOG HYBRIDO ABUT UNIV Ø3.3X6MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234476ANALOG HYBRIDO ABUT UNIV Ø3.3X4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234490ANALOG HYBRID MICRO MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234506ANALOG HYBRID 4.5IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234513ANALOG HYBRID 3.5IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234520ANALOG HYBRID 3.0IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234537ANALOG HYBRID HI Ø4.5MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234544ANALOG HYBRID HI Ø3.8MMSin Sistema de Implante Nacional S/ANDP2026-10-29