Helix Classic Reamers RSA-4/3

GUDID 07350081491918

3x Helix Classic Reamers for #4 Posts - 1.50 Short

Dentatus AB

Pin/post dental drill bit
Primary Device ID07350081491918
NIH Device Record Key1db3539c-b95b-449a-afbf-e8f04d222da2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHelix Classic Reamers
Version Model NumberRSA-4/3
Catalog NumberRSA-4/3
Company DUNS355803412
Company NameDentatus AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter
Outer Diameter1.5 Millimeter
Length28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107350081491918 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

[07350081491918]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-30
Device Publish Date2024-09-20

On-Brand Devices [Helix Classic Reamers]

073500814919493x Helix Classic Reamers for #6 Posts - 1.80 Short
073500814919323x Helix Classic Reamers for #5 Posts - 1.65 Short
073500814919183x Helix Classic Reamers for #4 Posts - 1.50 Short
073500814918953x Helix Classic Reamers for #3 Posts - 1.35 Short
073500814921372x Helix Classic Reamers for #5 Posts - 1.65 Extra Long
073500814921202x Helix Classic Reamers for #4 Posts - 1.50 Extra Long
073500814921133x Assorted Helix Classic Reamers - Sizes #3 to #5 Extra Long (1 of each size)
073500814921062x Helix Classic Reamers for #3 Posts - 1.35 Extra Long
073500814920693x Helix Classic Reamers for #6 Posts - 1.80 Long
073500814920523x Helix Classic Reamers for #5 Posts - 1.65 Long
073500814920453x Assorted Helix Classic Reamers - Sizes #4 to #6 Long (1 of each size)
073500814920383x Helix Classic Reamers for #4 Posts - 1.50 Long
073500814920143x Helix Classic Reamers for #3 Posts - 1.35 Long
073500814919253x Assorted Helix Classic Reamers - Sizes #4 to #6 Short (1 of each size)
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