FDA.reportPublic FDA data

Regard™

Primary DI
10194717120865
Brand
Regard™
Company
ROI CPS, LLC
Model
NU00698M
Device description
PELHAM ACDF
Published
2024-12-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJGNeurological Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717120862PackageGS12Not in Commercial Distribution
10194717120865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471712086220194717120862
1019471712086510194717120865

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
117174678
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
10194717102298Regard™UR00857C2019-11-21
10194717102304Regard™UR00858B2019-10-28
10194717111733Regard™GS00372E2025-03-30
10194717112488Regard™GS00237H2021-07-19
10194717112990Regard™LD01002CD2021-08-24
10194717113959Regard™GS00310D2021-11-29
10194717113973Regard™GS00311C2021-11-29
10194717114741Regard™PL00126ST2022-02-17
10194717115144Regard™HT00253H2022-03-23
10194717115175Regard™CV00256LM2022-03-23
10194717115830Regard™PL00126T2022-04-28
10194717116028Regard™ET00701GH2022-06-28
10194717116066Regard™HT00253I2022-07-14
10194717121305Regard™GS01065D2025-01-21
20194717102295Regard™UR00857C2019-11-21
10194717100355Regard™UR00279I2019-10-28
10194717100812Regard™UR00847B2019-11-14
10194717104797Regard™UR00739I2019-11-07
10194717104834Regard™UR00746G2019-10-28
10194717106609Regard™UR00746H2019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956493803CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956542174CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956556423CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956561304CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956568105CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956571211CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956573277CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956578746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956594289CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956598294CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600140CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600485CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601109CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601192CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601406CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601741CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956602045CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10809160540190HalyardAVID MEDICAL, INC.OJG2026-10-08
10198956141018CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956314351CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956458925CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956541559CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956541627CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956544918CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956550681CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956559790CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956561342CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956565968CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956587519CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06