FDA.report

SURGICAL INSTRUMENTATION

Primary DI
07290110723286
Brand
SURGICAL INSTRUMENTATION
Company
HI-TEC IMPLANTS LTD.
Model
SL-LIT-S
Catalog number
SL-LIT-S
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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290110723286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290110723286072901107232867290110723286

GMDN Terms

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
Moist Heat or Steam Sterilization;Liquid Chemical

Regulatory Flags

DUNS number
600710917
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
true
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
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
07290110729356HI-TEC IMPLANTSN-HC-3.5-3.5N-HC-3.5-3.52024-12-15
07290110729363HI-TEC IMPLANTSN-HC-3.5-4.5N-HC-3.5-4.52024-12-15
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
07290110729394HI-TEC IMPLANTSN-HC-4.5-6N-HC-4.5-62024-12-15
07290110728991UNIVERSAL UNITMU-HS-LMU-HS-L2024-11-28
07290110729004HI-TEC IMPLANTSNPI 3.5-8mmNPI 3.5-82024-11-28
07290110729011HI-TEC IMPLANTSNPI 3.5-10mmNPI 3.5-102024-11-28
07290110729028HI-TEC IMPLANTSNPI 3.5-11.5mmNPI 3.5-11.52024-11-28
07290110729035HI-TEC IMPLANTSNPI 3.5-13mmNPI 3.5-132024-11-28
07290110729042HI-TEC IMPLANTSNPI 3.5-16mmNPI 3.5-162024-11-28

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