FDA.reportPublic FDA data

Midway Select

Primary DI
00843717106944
Brand
Midway Select
Company
MIDWAY DENTAL SUPPLY, LLC
Model
002-0524
Device description
Paper Points, Taper .06, Size #20, 100pcs/box
Published
2021-04-05
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
true

Product Codes#

Code, Name table
CodeName
EKMGutta-Percha

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843717106941PrimaryGS10
00843717106944Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084371710694110843717106941
00843717106944008437171069448437171069440843717106944

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic filling/sealing materialA prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include, but are not limited to, silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). This GMDN code does not include gutta-percha. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
102354446
Device count
100
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10843717100574Midway Select002-00592019-01-14
10843717100598Midway Select002-00612019-01-14
10843717100734Midway Select002-00672019-01-14
10843717100758Midway Select002-00652019-01-14
10843717102547Midway Select002-02572019-07-19
10843717102721Midway Select002-02582019-07-19
10843717106699Midway Select002-04952021-04-05
10843717106705Midway Select002-04962021-04-05
10843717106712Midway Select002-04972021-04-05
10843717106729Midway Select002-04982021-04-05
10843717106736Midway Select002-04992021-04-05
10843717106743Midway Select002-05002021-04-05
10843717106750Midway Select002-05012021-04-05
10843717106767Midway Select002-05022021-04-05
10843717106774Midway Select002-05032021-04-05
10843717106781Midway Select002-05042021-04-05
10843717106798Midway Select002-05052021-04-05
10843717106804Midway Select002-05062021-04-05
10843717106811Midway Select002-05092021-04-05
10843717106828Midway Select002-05102021-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809263708607MX 02-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708614MX 02-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708621MX 02-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708638MX 02-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708645MX 02-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708652MX 02-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708720MX 04-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708737MX 04-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708744MX 04-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708751MX 04-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708768MX 04-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708775MX 04-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708843MX 06-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708850MX 06-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708867MX 06-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708874MX 06-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708881MX 06-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708898MX 06-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708904MG 02-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708911MG 02-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708928MG 02-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708935MG 02-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708942MG 02-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708959MG 02-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263709567MG 04-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263709574MG 04-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263709581MG 04-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263709598MG 04-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263709604MG 04-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263709611MG 04-40Meta Biomed Co., Ltd.EKM2026-10-28