ORI Self Donning Tabs Kit SF-SDT-1

GUDID 00854150007149

Surgical gown, single-use

Primary Device ID	00854150007149
NIH Device Record Key	602a6a75-cd6b-4e4a-82c6-4c5c90eff544
Commercial Distribution Status	In Commercial Distribution
Brand Name	ORI Self Donning Tabs Kit
Version Model Number	SF-SDT-1
Catalog Number	SF-SDT-1
Company DUNS	080246656
Company Name	OPERATING ROOM INNOVATIONS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00854150007132 [Primary]
GS1	00854150007149 [Package] Contains: 00854150007132 Package: Case [200 Units] In Commercial Distribution

FYA	Gown, Surgical

Steralize Prior To Use	false
Device Is Sterile	true

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