FDA.reportPublic FDA data

Regard™

Primary DI
10326053105262
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
303404
Published
2019-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRSI.V. Start Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10326053105262PackageGS1100In Commercial Distribution
20326053105269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1032605310526210326053105262
2032605310526920326053105269

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
134472476
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
00326053123528Regard™TLPCHCLR-REG2026-03-11
00326053123535Regard™TLPCHSTRP-REG2026-03-11
10326053117692Regard™A3PMSKUL4-REG2021-04-09
10326053117845Regard™A3SRGMSK2-REG2021-04-09
10326053117937Regard™VNYLEXMS3-REGVNYLEXMS3-REG2023-01-11
10326053117944Regard™VNYLEXMM3-REGVNYLEXMM3-REG2023-01-11
10326053117951Regard™VNYLEXML3-REGVNYLEXML3-REG2023-01-11
10326053117968Regard™VNYLEXMXL3-REGVNYLEXMXL3-REG2023-01-11
10326053117999Regard™A3SRGST4X-REG74713002021-04-20
20326053123164Regard™PVP1KIT- REG2025-08-15
10326053118026Regard™361066REG2025-06-10
10326053120777Regard™CVRBTELSXL-REGCVRBTELSXL-REG2025-02-06
10326053120784Regard™CVRBTTIEXL-REGCVRBTTIEXL-REG2025-01-28
20326053121528Regard™DBPCHILD-REG2024-12-02
20326053121535Regard™DBPSMADLT-REG2024-12-02
20326053121542Regard™DBPADLT-REG2024-12-02
20326053121559Regard™DBPADLTL-REG2024-12-02
20326053121566Regard™DBPLRGADLT-REG2024-12-02
20326053121573Regard™DBPLGADLTL-REG2024-12-02
20326053121580Regard™DBPTHIGH-REG2024-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160393306MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-26
50198956425345CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-23
50198956373141CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-19
50198956374711CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-19
50810010894927Aero-MedAERO-MED, LLCLRS2026-03-17
50810010894934Aero-MedAERO-MED, LLCLRS2026-03-17
00810010894977Aero-MedAERO-MED, LLCLRS2026-03-17
00810010894984Aero-MedAERO-MED, LLCLRS2026-03-17
50198956398571CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-16
50198956406597CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-16
50198956375428CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-10
10653160392576Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-05
10653160392637Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-05
10653160392682Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-05
20809160514938Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRS2026-03-04
50198956348828CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-03
20809160514754MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.LRS2026-03-03
20809160514761MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.LRS2026-03-03
50198956332063CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-02
50198956348446CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-02
10653160392583Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-02
10653160392323Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-26
10653160392385Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-26
10653160392460Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-26
50198956323528CARDINAL HEALTHCardinal Health 200, LLCLRS2026-02-23
50198956363616CARDINAL HEALTHCardinal Health 200, LLCLRS2026-02-23
10653160392057Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-11
10653160392064Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-11
10653160392231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-11
00842209137619NAR KitNORTH AMERICAN RESCUE, LLCLRS2026-02-10