FDA.reportPublic FDA data

Regard™

Primary DI
10194717120858
Brand
Regard™
Company
ROI CPS, LLC
Model
NU00974I
Device description
SPINE HC
Published
2024-12-26
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
20194717120855PackageGS11Not in Commercial Distribution
10194717120858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471712085520194717120855
1019471712085810194717120858

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
10809160528396HalyardAVID MEDICAL, INC.OJG2026-08-03
10809160528587HalyardAVID MEDICAL, INC.OJG2026-08-03
10198956327603CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956353961CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956504936CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956506947CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956513570CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956521346CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956524125CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956531130CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956534131CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956534674CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956538672CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956542297CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956542921CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10809160528242HalyardAVID MEDICAL, INC.OJG2026-07-31
10809160528129HalyardAVID MEDICAL, INC.OJG2026-07-30
10809160527887HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160527924HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160527986HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160528013HalyardAVID MEDICAL, INC.OJG2026-07-28
10809160528037HalyardAVID MEDICAL, INC.OJG2026-07-28
10197106927687CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956337404CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956416444CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956479364CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956480698CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956480919CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956494626CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956500075CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27