FDA.report

Midway Select

Primary DI
10843717101045
Brand
Midway Select
Company
MIDWAY DENTAL SUPPLY, LLC
Model
002-0102
Device description
Burs Finishing FG 7803, Pkg/5
Published
2018-11-19
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
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10843717101045PrimaryGS10
00843717101048Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084371710104510843717101045
00843717101048008437171010488437171010480843717101048

GMDN Terms

TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
102354446
Device count
5
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
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
10843717100536Midway Select002-00552019-01-14
10843717100512Midway Select002-00512018-11-19
10843717103414Midway Select002-03402019-07-19
10843717103384Midway Select002-03372019-07-19
10843717103407Midway Select002-03392019-07-19
10843717100079Midway Select002-0029002-00292018-08-23
10843717101120Midway Select002-00522018-11-19
10843717100505Midway Select002-00502018-11-19
10843717103391Midway Select002-03382019-07-19
00843717100492Midway Select002-00702022-08-31
00843717102632Midway Select002-02652022-08-26
00843717102649Midway Select002-02662022-08-26
00843717102656Midway Select002-02672022-08-26
00843717100485Midway Select002-01912022-08-26
00843717101147Midway Select002-01922022-08-26
00843717101154Midway Select002-01932022-08-26
00843717102144Midway Select002-02032022-08-26
00843717102151Midway Select002-02042022-08-26
00843717102168Midway Select002-02102022-08-26
00843717102175Midway Select002-02112022-08-26

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