FDA.report

Regard™

Primary DI
20326053100356
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
LZ0039
Published
2016-12-20
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
FDELaparoscopy Kit

Product Code Classifications

CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20326053100356PackageGS13Not in Commercial Distribution
10326053100359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2032605310035620326053100356
1032605310035910326053100359

GMDN Terms

TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. 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
true
No natural rubber latex
false
Sterilization required before use
false

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10326053120777Regard™CVRBTELSXL-REGCVRBTELSXL-REG2025-02-06
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20326053121528Regard™DBPCHILD-REG2024-12-02
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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

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