FDA.reportPublic FDA data

Regard™

Primary DI
20194717115011
Brand
Regard™
Company
ROI CPS, LLC
Model
ET01135A
Device description
DENTAL
Published
2022-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFXGeneral Purpose Dental Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFXGeneral Purpose Dental TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717115011PackageGS17In Commercial Distribution
10194717115014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711501120194717115011
1019471711501410194717115014

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, single-useA collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117174678
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
20194717102295Regard™UR00857C2019-11-21
20194717120879Regard™HT01025G2024-12-20
20194717120886Regard™LD00090U2024-12-20
20194717120893Regard™HT00074Y2024-12-20
20194717120916Regard™GS00802N2024-12-20
20194717120923Regard™OR01102D2024-12-20
20194717120930Regard™OR01103D2024-12-20
20194717120947Regard™GY013302025-01-16
20194717120954Regard™GY013312025-01-16
20194717121098Regard™GU013212025-01-16
20194717116766Regard™OR011092023-01-25
20194717116773Regard™OR011132023-01-25
20194717116780Regard™OR011112023-01-26
20194717116797Regard™OR011142023-01-27
20194717116803Regard™OR011082023-01-27
20194717116810Regard™OR011072023-01-31
20194717118715Regard™OR01103B2024-02-09
20194717118722Regard™OR01102B2024-02-13
20194717100918Regard™OR00355E2019-12-23
20194717103124Regard™OR00095U2019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956487093CARDINAL HEALTHCardinal Health 200, LLCOFX2026-05-25
50198956366891CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-23
50198956321296CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-19
50198956351705CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-10
50198956351743CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-10
50198956214741CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-09
50198956355024CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-06
50198956334357CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-03
50198956336641CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-03
50198956336627CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-02
50198956386998CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-02
50198956177091CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-23
50198956366457CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-23
50198956366884CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-13
50198956285253CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-02
50198956345179CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-02
50198956199673CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-30
50197106904334CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-23
50198956103137CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-05
50198956267006CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-31
50198956288452CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-17
50198956210057CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-10
50198956217704CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-09
50198956285031CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-09
50198956277593CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-28
50198956281576CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-25
50198956259179CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956266986CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956273199CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956158120CARDINAL HEALTHCardinal Health 200, LLCOFX2025-09-29