N/A

GUDID 00385640026079

SUMMIT MEDICAL, INC.

Tympanostomy tube
Primary Device ID00385640026079
NIH Device Record Key3ad542cc-9cae-4b7f-94ba-993f773d07ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number0205003
Company DUNS965484699
Company NameSUMMIT MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100385640026079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTube, Tympanostomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-10

On-Brand Devices [N/A]

00385640040358VC-49055
00385640039611V-49052
00385640035071PH-1000
00385640034241SM-40240
00385640034234RC-4100
00385640028806SM-40075
00385640028288OM-1001-SY
00385640027205VT-0401-01-P
00385640027113PRO-000-310
00385640027106PRO-000-111
00385640027090OM-4010-FX
00385640026314ET-TBDT-SF-40
003856400260790205003
00385640026017ET-TBDT-45
00385640025683OM-8782-R
00385640025676OM-8781-R
00385640025669OM-8780-R
00385640025294OM-1000-KS
00385640024709OM-1006-CO
00385640024693OM-1005-CO
00385640024686OM-1004-CO
00385640024679OM-1003-CO
00385640024662OM-1001-CO
00385640024655OM-1000-CO
00385640024112SM-45250
00385640024105SM-40242
00385640024099SM-40036
00385640024082SM-40014
00385640023580VC-49134
00385640023573VC-49144
00385640023436VC-49054
00385640023122ET-DSDT-45
00385640023108VC-49008
00385640023078VC-49005
003856400229890205006
00385640022903TE-7091-NS
00385640022897TE-7089-NS
00385640022873TE-7091-CE
00385640022859TE-7076-NS
00385640022842TE-7076-CE
00385640022637TE-7026-NS
00385640022620TE-7026-CE
00385640022514OM-4616-NM
00385640022507OM-4010-IN
00385640022477TE-7018-CE
00385640022385TE-7014-CE
00385640022354TE-7011-CE
00385640022293TE-7007-CE
003856400205720205012
003856400205650205009

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