FDA.report

Ditron Dental

Primary DI
07290109285689
Brand
Ditron Dental
Company
DITRON DENTAL LTD
Model
THSL-200220
Catalog number
THSL-200220
Device description
Long Manual Screwdriver Hex 1.25
Published
2021-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290109285689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290109285689072901092856897290109285689

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+97286711884info@ditrondental.com

Regulatory Flags

DUNS number
531878633
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
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 DIBrandModelCatalogPublished
07290109287263Ditron DentalSRA-SC3001SRA-SC30012025-04-09
07290109287270Ditron DentalSRA-TB4800SRA-TB48002025-04-09
07290109287287Ditron DentalSRA-TT4800SRA-TT48002025-04-09
07290109287294Ditron DentalTLI-LIB50TLI-LIB502025-04-09
07290109287300Ditron DentalTTI-C3500-08TTI-C3500-082025-04-09
07290109287317Ditron DentalTTI-C3500-15TTI-C3500-152025-04-09
07290109287324Ditron DentalTTI-C3500-25TTI-C3500-252025-04-09
07290109287331Ditron DentalTTI-C3500-35TTI-C3500-352025-04-09
07290109287348Ditron DentalTTI-C3500-45TTI-C3500-452025-04-09
07290109287355Ditron DentalTTI-C3501-08TTI-C3501-082025-04-09
07290109287362Ditron DentalTTI-C3501-15TTI-C3501-152025-04-09
07290109287379Ditron DentalTTI-C3501-25TTI-C3501-252025-04-09
07290109287386Ditron DentalTTI-C3501-35TTI-C3501-352025-04-09
07290109287393Ditron DentalTTI-C3501-45TTI-C3501-452025-04-09
07290109287409Ditron DentalTTI-C4500-08TTI-C4500-082025-04-09
07290109287416Ditron DentalTTI-C4500-15TTI-C4500-152025-04-09
07290109287423Ditron DentalTTI-C4500-25TTI-C4500-252025-04-09
07290109287430Ditron DentalTTI-C4500-35TTI-C4500-352025-04-09
07290109287447Ditron DentalTTI-C4501-08TTI-C4501-082025-04-09
07290109287454Ditron DentalTTI-C4501-15TTI-C4501-152025-04-09

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