FDA.reportPublic FDA data

TITAN IMPLANTS, INC.

Primary DI
00842448112194
Brand
TITAN IMPLANTS, INC.
Company
TITAN IMPLANT INC
Model
T-HSHD-035
Device description
"0.035"" Hex One Inch Driver for Implant Cover Screw"
Published
2017-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00842448112194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842448112194008424481121948424481121940842448112194

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
115545837
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842448116826TITAN IMPLANTS INC.BHI-35IA-AL2026-03-27
00842448115812TITAN IMPLANTS, INC.TS-38FTPME-2.02020-07-14
00842448118547TITAN IMPLANTS INCTIMZ-33IMEFS2026-02-18
00842448118479TITAN IMPLANTS INCH-4-5IA2026-02-17
00842448118486TITAN IMPLANTS INCTIMZ-4IME-4.02026-02-17
00842448118493TITAN IMPLANTS INCTIMZ-4TIE-4.02026-02-17
00842448118509TITAN IMPLANTS INCTIMZ-4TIE-2.02026-02-17
00842448118516TITAN IMPLANTS INCTIMZ-4IME-2.02026-02-17
00842448118424TITAN IMPLANTS INCC-3INTSLIAF-02-1.02026-01-11
00842448118431TITAN IMPLANTS INCSRS-43IA-L2026-01-11
00842448118448TITAN IMPLANTS INCLS-33PA2026-01-11
00842448118455TITAN IMPLANTS INCLS-4PA2026-01-11
00842448118462Titan Implants IncTC-3INTHA-B-3.02026-01-11
00842448118417Titan Implants IncIS-3NNIA-AL2026-01-08
00842448117342TITAN IMPLANTS INCMS-33IIC2026-01-01
00842448117410TITAN IMPLANTS INCDAB-3IIC2026-01-01
00842448117427TITAN IMPLANTS INCDAB-3IA-AL2026-01-01
00842448117519TITAN IMPLANTS INCTTM-4PSH2026-01-01
00842448117656TITAN IMPLANTS INCTN-CM16IAS2026-01-01
00842448117700TITAN IMPLANTS INCTIMZ-4CMIAS22026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013239MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013599MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013609MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013619MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013769MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013829MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA019019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028129MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028139MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028209MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028219MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08