Regard™

GUDID 20194717105357

ROI CPS, LLC

General/plastic surgical procedure kit, non-medicated, single-use
Primary Device ID20194717105357
NIH Device Record Key6cfa4a54-7315-4412-b564-cf893a0d9a30
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegard™
Version Model NumberGS00995A
Company DUNS117174678
Company NameROI CPS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110194717105350 [Primary]
GS120194717105357 [Package]
Contains: 10194717105350
Package: [2 Units]
In Commercial Distribution

FDA Product Code

LROGeneral Surgery Tray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [Regard™]

20194717105890ET01068
20194717105883GY01067A
20194717105869GS01065A
20194717105845SP01063A
20194717105364GS00996A
20194717105340OR00994B
20194717104961GS00773I
20194717104879GS00751H
20194717104848GY00747J
20194717104763OR00690M
20194717104657OR00451L
20194717104138GS00322J
20194717104022HT00235L
20194717103742NU00193L
20194717103735GS00191N
20194717103711CV00189H
20194717103513GS00153O
20194717103476GS00147G
20194717103421OB00142T
20194717103308GS00125U
20194717102936OR00058H
20194717102653LD00028P
20194717101199HT00386I
20194717101052LD00370H
20194717100963OR00360I
20194717100932CV00357D
20194717100659GU00700G
20194717100499ET00326I
20194717100338OR00277G
20194717100314GS00273G
20194717100222CV00261I
20194717100192OR00258G
20194717105326HT00992D
20194717105302HT00990C
20194717104671OR00453E
20194717104572GY00435P
20194717104527LD00427K
20194717104206CV00332O
20194717104077OR00296H
20194717103940LD00226K
20194717103810OR00209O
20194717103469GS00146L
20194717103445HT00144M
20194717103247OR00107D
20194717102974CV00077N
20194717102806OR00047N
20194717102349GS00999A
20194717102233GS00441P
20194717102226GY00436L
20194717102196GS00402A

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