FDA.reportPublic FDA data

Regard™

Primary DI
10326053100205
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
OR0022
Published
2018-03-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20326053100202PackageGS11Not in Commercial Distribution
10326053100205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2032605310020220326053100202
1032605310020510326053100205

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
945020902
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20326053123522Regard™TLPCHCLR-REG2026-03-11
20326053123539Regard™TLPCHSTRP-REG2026-03-11
10326053103015Regard™UN 401UN 4012023-08-17
10326053117340Regard™AN10842019-09-18
10326053118071Regard™DSPSCRBSHRTL-REGDSPSCRBSHRTL-REG2023-01-11
10326053118088Regard™DSPSCRBSHRTM-REGDSPSCRBSHRTM-REG2023-01-11
10326053118095Regard™DSPSCRBSHRTXL-REGDSPSCRBSHRTXL-REG2023-01-11
10326053118101Regard™DSPSCRBSHRTXXL-REGDSPSCRBSHRTXXL-REG2023-01-11
10326053118118Regard™DSPSCRBPNTL-REGDSPSCRBPNTL-REG2023-01-11
10326053118125Regard™DSPSCRBPNTM-REGDSPSCRBPNTM-REG2023-01-11
10326053118132Regard™DSPSCRBPNTXL-REGDSPSCRBPNTXL-REG2023-01-11
10326053118149Regard™DSPSCRBPNTXXL-REGDSPSCRBPNTXXL-REG2023-01-11
10326053118156Regard™CHMG38GNSM-REGCHMG38GNSM-REG2023-01-10
10326053118163Regard™CHMG38GNSL-REGCHMG38GNSL-REG2023-01-10
10326053118170Regard™CHMG38GNSXL-REGCHMG38GNSXL-REG2023-01-10
10326053118187Regard™CHMG38GNS2XL-REGCHMG38GNS2XL-REG2023-01-10
10326053118194Regard™CHMG53GNSM-REGCHMG53GNSM-REG2023-01-10
10326053118200Regard™CHMG53GNSL-REGCHMG53GNSL-REG2023-01-11
10326053118217Regard™CHMG53GNSXL-REGCHMG53GNSXL-REG2023-01-11
10326053118224Regard™CHMG53GNS2XL-REGCHMG53GNS2XL-REG2023-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS17809A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-07-22
10809160527603HALYARDAVID MEDICAL, INC.OJH2026-07-21
10198956180222CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956282360CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956291836CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956301573CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956307438CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956316515CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956338326CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956362208CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956370456CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956370982CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956372559CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956378421CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956379077CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956383302CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956387201CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956391673CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956392823CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956402676CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956416116CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956422506CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956440869CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956442290CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956455115CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956460775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956460874CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956461994CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956463110CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956463127CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20