FDA.report

Regard™

Primary DI
20194717109355
Brand
Regard™
Company
ROI CPS, LLC
Model
NU00921D
Device description
MAJOR CRANI
Published
2021-01-14
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

Related Records

Product Codes

CodeName
OJGNeurological Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20194717109355PackageGS11In Commercial Distribution
10194717109358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019471710935520194717109355
1019471710935810194717109358

GMDN Terms

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

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 DIBrandModelCatalogPublished
20194717102295Regard™UR00857C2019-11-21
20194717120879Regard™HT01025G2024-12-20
20194717120886Regard™LD00090U2024-12-20
20194717120893Regard™HT00074Y2024-12-20
20194717120916Regard™GS00802N2024-12-20
20194717120923Regard™OR01102D2024-12-20
20194717120930Regard™OR01103D2024-12-20
20194717120947Regard™GY013302025-01-16
20194717120954Regard™GY013312025-01-16
20194717121098Regard™GU013212025-01-16
20194717116766Regard™OR011092023-01-25
20194717116773Regard™OR011132023-01-25
20194717116780Regard™OR011112023-01-26
20194717116797Regard™OR011142023-01-27
20194717116803Regard™OR011082023-01-27
20194717116810Regard™OR011072023-01-31
20194717118715Regard™OR01103B2024-02-09
20194717118722Regard™OR01102B2024-02-13
20194717100918Regard™OR00355E2019-12-23
20194717103124Regard™OR00095U2019-11-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10198956376069CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956431744CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956435667CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956437463CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956445888CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956462342CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956463486CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956475625CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956477087CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956484702CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956485044CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956486515CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
50198956335569CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956359046CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956425833CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956427448CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50197106906055CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50197106926794CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956221060CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956292541CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956311020CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956313123CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956322132CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956323429CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956323665CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956324198CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956327106CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956329278CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956334463CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956334746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23