ORI SF-4XXL

GUDID 10854150007184

SF-4XXL

OPERATING ROOM INNOVATIONS, INC.

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use
Primary Device ID10854150007184
NIH Device Record Keyd97c245e-0aed-4548-8355-c623af5294d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameORI
Version Model NumberSF-4XXL
Catalog NumberSF-4XXL
Company DUNS080246656
Company NameOPERATING ROOM INNOVATIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Customer Support Contacts

Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com
Phone1-619-210-0371
Emailm.mcbride@orinnovations.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854150007187 [Primary]
GS110854150007184 [Package]
Contains: 00854150007187
Package: Case [24 Units]
In Commercial Distribution

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2017-10-24

On-Brand Devices [ORI]

10854150007238UH-3 –Face Shield, attached with Full Covering
10854150007184SF-4XXL
00854150007170Solofit AAMI IV SMS Gown L4 Reinforced, x-Large
10854150007153Solofit AAMI IV SMS Gown L4 Reinforced, Large
00850003355047Solofit AAMI IV SMS Gown L4, XXL, Extra Long
00850003355023Solofit AAMI IV SMS Gown L4, XL, Extra Long
00854150007279ORI-Specialty Drape Line-Lower Extremity Adaptable Drape
00854150007293SmokeStop - Smoke Evacuation Kit
00854150007330HaloFit XX-Large with Face Shield AAMI 4
00854150007316HaloFit X-Large with Face Shield AAMI 4
00854150007354SmokeStop - Smoke Evacuation Kit 20" Tubing
26975085708777Solofit AAMI IV SMS Gown XXXL, Extra Long
26975085708760Solofit AAMI IV SMS Gown XXL, Extra Long
26975085708753Solofit AAMI IV SMS Gown XXL
26975085708746Solofit AAMI IV SMS Gown XL, Extra Long
26975085708739Solofit AAMI IV SMS Gown XL
26975085708722Solofit AAMI IV SMS Gown XL, Extra Long
26975085708715Solofit AAMI IV SMS Gown L
26975085708708Solofit AAMI III SMS Gown XX-Large
26975085708692Solofit AAMI III SMS Gown X-Large
26975085708685Solofit AAMI III SMS Gown Poly Reinforced XXX-Large
26975085708678Solofit AAMI III SMS Gown Poly Reinforced XX-Large
26975085708661Solofit AAMI III SMS Gown Poly Reinforced X-Large
26975085708654Solofit AAMI III SMS Gown Poly Reinforced Large
26975085708647Solofit AAMI III SMS Gown Large
26975085708630HaloFit XX-Large with Face Shield AAMI IV
26975085708623HaloFit X-Large with Face Shield AAMI IV
06975085708612Specialty Drape Line-Lower Extremity Adaptable Drape
26975085708609Specialty Drape Line-Direct Anterior Hip
26975085708593SmokeStop - Smoke Evacuation
26975085708555Beach Chair Shoulder Drape, Tri-Lam, w/ Pouch
26975085708524SterileBack Toga XL-EL w. Face Shield
26975085708333SmokeStop - Smoke Evacuation 20" Tubing
26975424191475Face Shield, Attached w. AAMI IV Head Covering
26975424191468ORI Drop Stop
26975424191451Face Shield, Attached with Full Head Covering
16975085709418HaloFit XXX-Large with Face Shield AAMI IV
16975085709401HaloFit Large with Face Shield AAMI IV
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