FDA.reportPublic FDA data

Regard™

Primary DI
20194717104343
Brand
Regard™
Company
ROI CPS, LLC
Model
PL00390F
Published
2020-01-03
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
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
20194717104343PackageGS14In Commercial Distribution
10194717104346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710434320194717104343
1019471710434610194717104346

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery 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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40198459454678MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459454814MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459460686MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459462475MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459469887MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459469894MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459470395MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459471019MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459472610MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459473761MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459473792MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459473945MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459474454MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459474560MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459475925MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459479671MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459479688MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459443276MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459444518MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459450557MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459450564MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459453473MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459455590MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459455682MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459456344MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459457334MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459460297MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459463854MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459464523MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459466398MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11