INSTRUSFAE

GUDID 00385640028578

SUMMIT MEDICAL, INC.

Instrument tray
Primary Device ID00385640028578
NIH Device Record Keyf459b830-b01b-4bcd-bb7e-b0302b58d621
Commercial Distribution StatusIn Commercial Distribution
Brand NameINSTRUSFAE
Version Model NumberIN-2020-1725
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100385640028578 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-08-09
Device Publish Date2017-06-10

On-Brand Devices [INSTRUSFAE]

00385640028639IN-2020-1744
00385640028578IN-2020-1725
00385640004503IN-7274-NF

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