INSTRUSAFE

GUDID 00385640048781

SUMMIT MEDICAL, INC.

Instrument tray
Primary Device ID00385640048781
NIH Device Record Key2a7fbfac-f440-4a05-ac4c-9d82afe36dc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameINSTRUSAFE
Version Model NumberIN-2020-3722
Company DUNS965484699
Company NameSUMMIT MEDICAL, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100385640048781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [INSTRUSAFE]

00385640042079IN-2020-3006
00385640042062IN-2020-2184
00385640042055IN-2020-2915
00385640042048IN-2020-2183
00385640042031IN-2020-3008
00385640042024IN-2020-3031
00385640042017IN-2020-2931
00385640042000IN-6033-NF
00385640041997IN-6033-R
00385640041980IN-2020-2964
00385640041973IN-2600-15-EN-041
00385640041966IN-2600-14-EN-022
00385640041959IN-2600-14-EN-021
00385640041942IN-2020-2613
00385640041935IN-2020-2610
00385640041928IN-2020-2759
00385640041911IN-2020-2758
00385640041904IN-2020-2614
00385640041898IN-2020-2321
00385640041881IN-8893-01-TF
00385640041867IN-2020-2966
00385640041850IN-2020-2661
00385640041843IN-2020-2582
00385640041836CS-0100
00385640041829CS-0300
00385640041812CS-0210
00385640041805CS-0200
00385640041799IN-2020-2854
00385640041782IN-2020-2941
00385640041775IN-2020-2850
00385640041768IN-2020-2581
00385640041744IN-2020-2960
00385640041737IN-2020-2755
00385640041720IN-2020-2193
00385640041713IN-2020-2896
00385640041706IN-2020-2895
00385640041690IN-2020-2580
00385640041683IN-2020-2579
00385640041676IN-2020-2578
00385640041669IN-2020-2940
00385640041652IN-2020-2926
00385640041645IN-2020-2955
00385640041638IN-2020-2954
00385640041621IN-2020-2918
00385640041614IN-2020-2218
00385640041607OM-1002-KT
00385640041591IN-2020-2937
00385640041553IN-2020-2182
00385640041539IN-2020-2933
00385640041522IN-2020-2607

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