Regard™

Primary DI
20326053113196
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
GY0688
Published
2017-05-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20326053113196PackageGS12Not in Commercial Distribution
10326053113199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2032605311319620326053113196
1032605311319910326053113199

GMDN Terms#

Term, Definition table
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 table
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 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