FDA.reportPublic FDA data

Regard™

Primary DI
20326053113806
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
OR0973
Published
2017-11-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
20326053113806PackageGS12Not in Commercial Distribution
10326053113809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2032605311380620326053113806
1032605311380910326053113809

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
945020902
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
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
10809160537817HALYARDAVID MEDICAL, INC.OJH2026-09-19
10809160537534HALYARDAVID MEDICAL, INC.OJH2026-09-18
B098AMS17151B0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-18
B098AMS195590Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-18
B098AMS197480Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-18
B098AMS197680Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-18
B098AMS7712B0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-18
10198956379084CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956421462CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956454989CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956468399CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956484795CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956505919CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956507678CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956507975CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956509061CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956509108CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956514423CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956519404CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956530003CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956530775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956533783CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956533844CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956538696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956544246CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956545137CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956545595CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956547612CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551732CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04