FDA.report

Regard™

Primary DI
20326053100486
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
LD0109
Published
2019-01-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OHMCesarean Section Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20326053100486PackageGS12Not in Commercial Distribution
10326053100489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2032605310048620326053100486
1032605310048910326053100489

GMDN Terms

TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
945020902
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 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 DIBrandCompanyProduct codePublished
10198956388345CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956457683CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956477575CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956479654CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956479760CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956483026CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956484924CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485181CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485495CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485532CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485631CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956488632CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956488786CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
50198956424560CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-24
50198956427455CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-24
50198956337099CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956343434CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956387506CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956402094CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956410181CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956412758CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956414080CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956418002CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956419825CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956420838CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956424324CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956366082CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19
50198956373592CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19
50198956376395CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19
50198956390216CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19