FDA.reportPublic FDA data

Regard™

Primary DI
20194717118456
Brand
Regard™
Company
ROI CPS, LLC
Model
NU01141C
Device description
CRANIOTOMY
Published
2024-01-29
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
20194717118456PackageGS12In Commercial Distribution
10194717118459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711845620194717118456
1019471711845910194717118459

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
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
10198956496842CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956496859CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956498235CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956499478CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10809160522417HalyardAVID MEDICAL, INC.OJG2026-06-02
10198956352711CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956362611CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956384422CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956400238CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956450530CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956454897CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956473218CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956475571CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956480629CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956487178CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956487536CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956489288CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956489325CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956491168CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956493056CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10809160521908HalyardAVID MEDICAL, INC.OJG2026-05-27
10193489375657NAMICMEDLINE INDUSTRIES, INC.OJG2026-05-21
10193489376845NAMICMEDLINE INDUSTRIES, INC.OJG2026-05-21
10080196471096NAMICMEDLINE INDUSTRIES, INC.OJG2026-04-24