FDA.report

TREPHINE DRILL

Primary DI
07290113355965
Brand
TREPHINE DRILL
Company
DENTIN IMPLANTS TECHNOLOGIES LTD
Model
DDR-TR05
Device description
Surgical Trephine Drill-5mmd
Published
2018-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290113355965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290113355965072901133559657290113355965

GMDN Terms

TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
600215680
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
07290113356832PROSTHETIC SCREWSDTR-SC112019-05-15
07290113355880CONICAL DRILLDDR-C0282018-09-10
07290113355897CONICAL DRILLDDR-C0322018-09-10
07290113355903CONICAL DRILLDDR-C0372018-09-10
07290113355910CONICAL DRILLDDR-C0412018-09-10
07290113355927CONICAL DRILLDDR-C0452018-09-10
07290113355934CONICAL DRILLDDR-C0562018-09-10
07290113356313IMPLANTOLOGY TOOLSDCT-08502018-09-10
07290113356405CONICAL DRILLDDR-C0272019-01-20
07290113356412CONICAL DRILLDDR-C0422019-01-20
07290113356429CONICAL DRILLDDR-C0472019-01-20
07290113356436CONICAL DRILLDDR-C0522019-01-20
07290113356245IMPLANTOLOGY TOOLSDCT-07002018-09-10
07290113356856ANATOMIC ABUTMENTSAP-15012019-07-30
07290113356863ANATOMIC ABUTMENTSAP-15022019-07-30
07290113356870ANATOMIC ABUTMENTSAP-15032019-07-30
07290113356887ANATOMIC ABUTMENTSAP-25012019-07-30
07290113356894ANATOMIC ABUTMENTSAP-25022019-07-30
07290113356900ANATOMIC ABUTMENTSAP-25032019-07-30
07290113356818MULTI UNIT ACCESSORIESPSU-00322019-04-17

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