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

GUDID 00085415000703

OPERATING ROOM INNOVATIONS, INC.

Operating room gown, single-use
Primary Device ID00085415000703
NIH Device Record Keydfabbf7d-3508-4910-b717-5ff8c8b55a15
Commercial Distribution StatusIn Commercial Distribution
Brand NameSF-3L Solofit AAMI III SMS Gown Large
Version Model NumberSF-3L
Catalog NumberSF-3L
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

Phone7166810866
Emailrdean@exactmm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100085415000703 [Package]
Contains: 00854150007026
Package: Case [36 Units]
In Commercial Distribution
GS100854150007026 [Primary]

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-03-02

On-Brand Devices [SF-3L Solofit AAMI III SMS Gown Large]

00085415000703SF-3L
00854150007033SF-3L

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