SF-3L Solofit AAMI III SMS Gown Large SF-3L

GUDID 00854150007033

Surgical gown, single-use

Primary Device ID	00854150007033
NIH Device Record Key	dfabbf7d-3508-4910-b717-5ff8c8b55a15
Commercial Distribution Status	In Commercial Distribution
Brand Name	SF-3L Solofit AAMI III SMS Gown Large
Version Model Number	SF-3L
Catalog Number	SF-3L
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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00854150007026 [Primary]
GS1	00854150007033 [Package] Contains: 00854150007026 Package: Case [36 Units] In Commercial Distribution

FYA	Gown, Surgical

Steralize Prior To Use	false
Device Is Sterile	true

00085415000703	SF-3L
00854150007033	SF-3L