FDA.reportPublic FDA data

Regard™

Primary DI
00326053109294
Brand
Regard™
Company
ROI CPS, LLC
Model
361093REG
Device description
Suture Removal Kit
Published
2023-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MCZSuture Removal Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCZSuture Removal KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10326053109291PackageGS150In Commercial Distribution
00326053109294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1032605310929110326053109291
00326053109294003260531092943260531092940326053109294

GMDN Terms#

Term, Definition table
TermDefinition
Suture kit, non-medicatedA collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. 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
No natural rubber latex
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
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
10198956404304CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-04-15
10704411018834AMSure ® SUTURE REMOVAL KITAMSINO INTERNATIONAL, INC.MCZ2026-04-03
10704411018841AMSure ® Suture Removal KitAMSINO INTERNATIONAL, INC.MCZ2026-04-03
10704411018858AMSure ® Suture Removal KitAMSINO INTERNATIONAL, INC.MCZ2026-04-03
10198956291362CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-03-26
10198956326873CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-03-16
10198956228993CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-02-09
10198956254770CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-12-02
10198956241046CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-11-19
10198956260030CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-11-13
10198956160439CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-08-28
10198956112483CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-07-09
10198956057920CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-06-05
10198956053960CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-05-16
10198459280498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10198459280566Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10198459280573Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10198459281778Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10197106916186CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-02-17
10197106818459CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-12-13
10197106828960CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-11-22
10198459182730Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-11-17
10197106833131CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-11-13
10198459137402Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-11-03
10198459120886Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-10-20
10198459145063Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-10-13
10198459137396Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-10-06
10197106752173CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-09-17
10198459090202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-09-08
10198459092350Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-09-08