ORI ORI-SDL-LEAD

GUDID 00854150007279

ORI-Specialty Drape Line-Lower Extremity Adaptable Drape

OPERATING ROOM INNOVATIONS, INC.

Patient surgical drape, single-use, sterile
Primary Device ID00854150007279
NIH Device Record Keyabfcf92c-c8a3-47e9-8555-e26f52f31903
Commercial Distribution StatusIn Commercial Distribution
Brand NameORI
Version Model NumberORI-SDL-LEAD
Catalog NumberORI-SDL-LEAD
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100854150007262 [Primary]
GS100854150007279 [Package]
Contains: 00854150007262
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-08
Device Publish Date2020-06-30

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00850003355023Solofit AAMI IV SMS Gown L4, XL, Extra Long
00854150007279ORI-Specialty Drape Line-Lower Extremity Adaptable Drape
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26975085708746Solofit AAMI IV SMS Gown XL, Extra Long
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26975085708661Solofit AAMI III SMS Gown Poly Reinforced X-Large
26975085708654Solofit AAMI III SMS Gown Poly Reinforced Large
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26975085708630HaloFit XX-Large with Face Shield AAMI IV
26975085708623HaloFit X-Large with Face Shield AAMI IV
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26975424191468ORI Drop Stop
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16975085709401HaloFit Large with Face Shield AAMI IV
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