DS-100 ORI Drop Stop Kit DS-100

GUDID 00854150007125

OPERATING ROOM INNOVATIONS, INC.

Patient surgical drape, single-use, sterile Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use
Primary Device ID00854150007125
NIH Device Record Keyf3a6d533-f5b2-4e3a-b5d7-e5f794b2b721
Commercial Distribution StatusIn Commercial Distribution
Brand NameDS-100 ORI Drop Stop Kit
Version Model NumberDS-100
Catalog NumberDS-100
Company DUNS080246656
Company NameOPERATING ROOM INNOVATIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854150007118 [Primary]
GS100854150007125 [Package]
Contains: 00854150007118
Package: Case [40 Units]
In Commercial Distribution

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-08
Device Publish Date2017-03-02

Devices Manufactured by OPERATING ROOM INNOVATIONS, INC.

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26975424191451 - ORI2023-04-12 Face Shield, Attached with Full Head Covering
26975424191468 - ORI2023-04-12 ORI Drop Stop
26975424191475 - ORI2023-04-12 Face Shield, Attached w. AAMI IV Head Covering
26975085708333 - ORI2023-04-11 SmokeStop - Smoke Evacuation 20" Tubing
26975085708524 - ORI2023-04-11 SterileBack Toga XL-EL w. Face Shield

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