FDA.reportPublic FDA data

Regard™

Primary DI
10194717114741
Brand
Regard™
Company
ROI CPS, LLC
Model
PL00126ST
Device description
General Plastics
Published
2022-02-17
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
FTNPlastic Surgery And Accessories Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTNPlastic Surgery And Accessories KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717114748PackageGS12Not in Commercial Distribution
10194717114741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711474820194717114748
1019471711474110194717114741

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
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
10194717110422Regard™UR011502021-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196920846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2025-01-19
10193489425918Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-07-29
10193489434392Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-07-29
10193489214390Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489214475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489215519Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489406696Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489414936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489416138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489416183Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489418828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419399Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419450Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419597Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419726Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419733Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489421743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489424171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489424850Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489426311Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489427073Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429114Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429299Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429305Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489439175Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489441352Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489441635Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489442670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489442687Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08