FDA.reportPublic FDA data

Regard™

Primary DI
20194717117329
Brand
Regard™
Company
ROI CPS, LLC
Model
ET00837D
Device description
MICROLARYNGOSCOPY
Published
2023-05-18
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
OGREar, Nose, And Throat Surgical Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717117329PackageGS14In Commercial Distribution
10194717117322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711732920194717117329
1019471711732210194717117322

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical 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
10080196884704Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2025-01-19
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H65857031985Henry ScheinHENRY SCHEIN, INC.OGR2022-09-19
10193489063912Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-19
10193489287547Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489288261Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489290424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489290691Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
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10193489290912Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292008Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292015Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292503Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292596Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
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10193489297287Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489299120Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489299977Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489300598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489301564Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09