FDA.reportPublic FDA data

NA

Primary DI
ENTTW11THO0001
Brand
NA
Company
NT-Trading GmbH & Co. KG
Model
W 11.THO.000
Catalog number
W 11.THO.000
Device description
Screwdriver
Published
2023-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
ENTTW11THO0001PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497219619990xx@xx.xx

Regulatory Flags#

DUNS number
312800478
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ENTTTA9S3D3745N/ATA 9.S33D3.7452023-10-16
ENTTBEG9S3D32371NABEG 9.S3D3.237BEG 9.S3D3.2372023-07-21
ENTTBEG9S3D41001NABEG 9.S3D4.100BEG 9.S3D4.1002023-07-21
ENTTBEG9S3D45001NABEG 9.S3D4.500BEG 9.S3D4.5002023-07-21
ENTTBEG9S3D55001NABEG 9.S3D5.500BEG 9.S3D5.5002023-07-21
ENTTBIO9S3D30001NABIO 9.S3D3.000BIO 9.S3D3.0002023-07-21
ENTTBIO9S3D35001NABIO 9.S3D3.500BIO 9.S3D3.5002023-07-21
ENTTBIO9S3D45001NABIO 9.S3D4.500BIO 9.S3D4.5002023-07-21
ENTTBIO9S3D57001NABIO 9.S3D5.700BIO 9.S3D5.7002023-07-21
ENTTBRE9S3D35401NABRE 9.S3D3.540BRE 9.S3D3.5402023-07-21
ENTTCAM9S3D33001NACAM 9.S3D3.300CAM 9.S3D3.3002023-07-21
ENTTCAM9S3D38001NACAM 9.S3D3.800CAM 9.S3D3.8002023-07-21
ENTTCAM9S3D43001NACAM 9.S3D4.300CAM 9.S3D4.3002023-07-21
ENTTCAM9S3D50601NACAM 9.S3D5.060CAM 9.S3D5.0602023-07-21
ENTTCOL9S3D33001NACOL 9.S3D3.300COL 9.S3D3.3002023-07-21
ENTTCOL9S3D38431NACOL 9.S3D3.843COL 9.S3D3.8432023-07-21
ENTTCOL9S3D50001NACOL 9.S3D5.000COL 9.S3D5.0002023-07-21
ENTTE9S3D35001NAE 9.S3D3.500E 9.S3D3.5002023-07-21
ENTTE9S3D43001NAE 9.S3D4.300E 9.S3D4.3002023-07-21
ENTTE9S3D50001NAE 9.S3D5.000E 9.S3D5.0002023-07-21

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
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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