FDA.reportPublic FDA data

UMarc

Primary DI
20860012076615
Brand
UMarc
Company
New Venture Enterprise Ltd.
Model
WWS
Device description
Disposable Orthodontic Archwire White Markers
Published
2024-07-03
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
EMPMarker, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMPMarker, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860012076615PackageGS1100In Commercial Distribution
00860012076611PrimaryGS10
10860012076618Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086001207661520860012076615
00860012076611008600120766118600120766110860012076611
1086001207661810860012076618

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry, well ventilated storage area away from direct sunlight. Do not store near oxidizing agents or strong acids.
Storage Environment Temperature0 Degrees Fahrenheit125 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119292228
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
true
Expiration date on label
false
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
00860012076604UMarcOWS2024-07-03
00860012076611UMarcWWS2024-07-03
10860012076601UMarcOWS2024-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251436943805KOHLERKohler Medizintechnik GmbHEMP2026-03-12
00841336108622Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMP2025-11-11
00860012076604UMarcNew Venture Enterprise Ltd.EMP2024-07-03
00860012076611UMarcNew Venture Enterprise Ltd.EMP2024-07-03
10860012076601UMarcNew Venture Enterprise Ltd.EMP2024-07-03
00841336101760Salvin Stainless Steel UNC ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-08-21
00841336105430Perio Probe BlackSALVIN DENTAL SPECIALTIES, LLCEMP2023-08-10
00841336101791Salvin Titanium CP12 Perio ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-07-31
00841336101807Salvin Titanium UNC-15 Perio ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-07-31
10889950086527Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMP2023-04-07
00887919771371Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771432Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771463Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771494Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
04251436904646KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436904936KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905032KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905049KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905056KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905063KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436925818KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436925856KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436930621KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436931253KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436931260KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436933141KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
00840105217442ZOLL-DENTALZoll-DentalEMP2021-03-10
00840105217459ZOLL-DENTALZoll-DentalEMP2021-03-10
10381780450283Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEMP2018-02-26
10381780450290Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEMP2018-02-26