FDA.reportPublic FDA data

DRIVER HANDP. IMP. MT16° GUIDED NARROW

Primary DI
07899995234377
Brand
DRIVER HANDP. IMP. MT16° GUIDED NARROW
Company
Sin Sistema de Implante Nacional S/A
Model
CTMTG 01E
Catalog number
CTMTG 01E
Device description
DRIVER HANDP. IMP. MT16° GUIDED NARROW
Published
2026-10-29
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
false

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
07899995234377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995234377078999952343777899995234377

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
904569092
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
07899995223999ORGANIZER BOX VERSALISCOSV 01ENCOSV 01EN2026-10-29
07899995226457SLEEVE FOR SURGICAL GUIDEØ5.1MM OPENAGA 51-10AGA 51-102026-10-29
07899995226464SLEEVE FOR SURGICAL GUIDE Ø5.1MM OPENAGA 51-5AGA 51-52026-10-29
07899995226471SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPENAGA 39-10AGA 39-102026-10-29
07899995226488SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPENAGA 39-5AGA 39-52026-10-29
07899995226495SLEEVE FOR SURGICAL GUIDE Ø5.1MMAG 51-10AG 51-102026-10-29
07899995226501SLEEVE FOR SURGICAL GUIDE Ø5.1MMAG 51-5AG 51-52026-10-29
07899995226518SLEEVE FOR SURGICAL GUIDE Ø3.9MMAG 39-10AG 39-102026-10-29
07899995226525SLEEVE FOR SURGICAL GUIDE Ø3.9MMAG 39-5AG 39-52026-10-29
07899995226532SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALAFGP 20-10AFGP 20-102026-10-29
07899995226556SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALAFGP 20-5AFGP 20-52026-10-29
07899995226563SLEEVE FOR FIXER GUIDE Ø1.4MMAFG 14-10AFG 14-102026-10-29
07899995234322Organizar Box Beyond Full Arch SurgicalCOBFA 01COBFA 012026-10-29
07899995234339Organizer Box Intraoral Pro Scanning StarterCOIPSSCOIPSS2026-10-29
07899995234346DRIVER RATCHET IMP. MT16° GUIDEDCCMTG 01CCMTG 012026-10-29
07899995234353DRIVER RATCHET IMP. MT16° GUIDED NARROWCCMTG 01ECCMTG 01E2026-10-29
07899995234360DRIVER HANDP. IMP. MT16° GUIDEDCTMTG 01CTMTG 012026-10-29
07899995234391ANALOG REVERSE MICRO MINI ABUT.ARMMAARMMA2026-10-29
07899995234407ANALOG REVERSE MINI ABUT.ARMAARMA2026-10-29
07899995234414ANALOG REVERSE CM11.5°ARCMARCM2026-10-29

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
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
07899995234551ANALOG HYBRID HE Ø5.0MMSin Sistema de Implante Nacional S/ANDP2026-10-29