FDA.reportPublic FDA data

Regard™

Primary DI
20194717106675
Brand
Regard™
Company
ROI CPS, LLC
Model
NU00140AB
Published
2020-01-10
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
OJGNeurological Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717106675PackageGS11In Commercial Distribution
10194717106678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710667520194717106675
1019471710667810194717106678

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.

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
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
10198956336865CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
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10198956496064CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
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10198956498273CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956501737CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956503496CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956332522CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956400726CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956429604CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956450486CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956457416CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956460591CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956472167CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956483071CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956486089CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956492516CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
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10198956495111CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495487CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495975CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956498280CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10809160522561HalyardAVID MEDICAL, INC.OJG2026-06-04
10809160522578HalyardAVID MEDICAL, INC.OJG2026-06-04
10809160522615HalyardAVID MEDICAL, INC.OJG2026-06-04
10198956477452CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956483910CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956492257CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03