FDA.reportPublic FDA data

-

Primary DI
ENTTW11NEOG021
Brand
-
Company
NT-Trading GmbH & Co. KG
Model
W 11.NEO.G02
Catalog number
W 11.NEO.G02
Device description
Screwdriver, ISO shaft
Published
2023-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
ENTTW11NEOG021PrimaryHIBCC0

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
ENTTTA9S3D3745N/ATA 9.S33D3.7452023-10-16
ENTTBEG5LA32371-BEG 5.LA3.237BEG 5.LA3.2372023-07-21
ENTTBEG5LA41001-BEG 5.LA4.100BEG 5.LA4.1002023-07-21
ENTTBEG5LA45001-BEG 5.LA4.500BEG 5.LA4.5002023-07-21
ENTTBEG5LA55001-BEG 5.LA5.500BEG 5.LA5.5002023-07-21
ENTTBEG9S3D32371-BEG 9.S3D3.237BEG 9.S3D3.2372023-07-21
ENTTBEG9S3D41001-BEG 9.S3D4.100BEG 9.S3D4.1002023-07-21
ENTTBEG9S3D45001-BEG 9.S3D4.500BEG 9.S3D4.5002023-07-21
ENTTBEG9S3D55001-BEG 9.S3D5.500BEG 9.S3D5.5002023-07-21
ENTTBEGTR0001321-BEG TR-00013.2BEG TR-00013.22023-07-21
ENTTBEGTR00024211-BEG TR-00024.2BEG TR-00024.22023-07-21
ENTTBEGTR0003451-BEG TR-00034.5BEG TR-00034.52023-07-21
ENTTBEGTR0004551-BEG TR-00045.5BEG TR-00045.52023-07-21
ENTTBIO5LA30001-BIO 5.LA3.000BIO 5.LA3.0002023-07-21
ENTTBIO5LA35001-BIO 5.LA3.500BIO 5.LA3.5002023-07-21
ENTTBIO5LA45001-BIO 5.LA4.500BIO 5.LA4.5002023-07-21
ENTTBIO5LA57001-BIO 5.LA5.700BIO 5.LA5.7002023-07-21
ENTTBIO9S3D30001-BIO 9.S3D3.000BIO 9.S3D3.0002023-07-21
ENTTBIO9S3D35001-BIO 9.S3D3.500BIO 9.S3D3.5002023-07-21
ENTTBIO9S3D45001-BIO 9.S3D4.500BIO 9.S3D4.5002023-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800020802767ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802774ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802781ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802798ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802804ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802811ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802828ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802842ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802859SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802866SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802873SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802880SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802897SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802903SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802910SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802927SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802934SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803009SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803016SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803023SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803030SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803047SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803054SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803061SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803085SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020858948ABIDING MU LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020859372ABIDING COUPLE DIGITAL LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26