ORI SF-3PLB

GUDID 26975085708654

Solofit AAMI III SMS Gown Poly Reinforced Large

OPERATING ROOM INNOVATIONS, INC.

Surgical gown, single-use
Primary Device ID26975085708654
NIH Device Record Keye3e82a39-f525-47d8-a356-1e64a2099e10
Commercial Distribution StatusIn Commercial Distribution
Brand NameORI
Version Model NumberSF-3PLB
Catalog NumberSF-3PLB
Company DUNS080246656
Company NameOPERATING ROOM INNOVATIONS, INC.
Device Count1
DM Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS106975085708650 [Primary]
GS126975085708654 [Package]
Contains: 06975085708650
Package: Case [25 Units]
In Commercial Distribution

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-11
Device Publish Date2023-04-03

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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