FDA.reportPublic FDA data

SURGICAL INSTRUMENTATION

Primary DI
07290110723392
Brand
SURGICAL INSTRUMENTATION
Company
HI-TEC IMPLANTS LTD.
Model
RV-FT-L
Catalog number
RV-FT-L
Device description
TOOL
Published
2017-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110723392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110723392072901107233927290110723392

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Liquid Chemical"", ""Moist Heat or Steam Sterilization""]"
Liquid Chemical;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600710917
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290110729240HI-TEC IMPLANTSN-BBA-3N-BBA-32024-12-16
07290110729257HI-TEC IMPLANTSN-BBA-4N-BBA-42024-12-16
07290110729264HI-TEC IMPLANTSN-BBA-5N-BBA-52024-12-16
07290110729288HI-TEC IMPLANTSN-MU-1N-MU-12024-12-16
07290110729295HI-TEC IMPLANTSN-MU-2N-MU-22024-12-16
07290110729301HI-TEC IMPLANTSN-MU-3N-MU-32024-12-16
07290110729318HI-TEC IMPLANTSN-MU-4N-MU-42024-12-16
07290110729325HI-TEC IMPLANTSN-MU-17N-MU-172024-12-16
07290110729332HI-TEC IMPLANTSN-MU-30N-MU-302024-12-16
07290110729158HI-TEC IMPLANTSN-AATN-AAT2024-12-15
07290110729165HI-TEC IMPLANTSN-AAT-LN-AAT-L2024-12-15
07290110729172HI-TEC IMPLANTSN-ACA-1.5N-ACA-1.52024-12-15
07290110729189HI-TEC IMPLANTSN-ACA-2.5N-ACA-2.52024-12-15
07290110729196HI-TEC IMPLANTSN-ACA-3.5N-ACA-3.52024-12-15
07290110729202HI-TEC IMPLANTSN-ACA-4.5N-ACA-4.52024-12-15
07290110729219HI-TEC IMPLANTSN-ACA-PN-ACA-P2024-12-15
07290110729226HI-TEC IMPLANTSN-ANA-17-1.5N-ANA-17-1.52024-12-15
07290110729233HI-TEC IMPLANTSN-BBA-2N-BBA-22024-12-15
07290110729370HI-TEC IMPLANTSN-HC-4.5-3N-HC-4.5-32024-12-15
07290110729387HI-TEC IMPLANTSN-HC-4.5-4.5N-HC-4.5-4.52024-12-15

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Primary DI, Brand, Company table
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