na

GUDID 00385640026925

SUMMIT MEDICAL, INC.

Tympanostomy tube
Primary Device ID00385640026925
NIH Device Record Key9e9204b5-77a9-40fb-882e-fd205c397118
Commercial Distribution StatusIn Commercial Distribution
Brand Namena
Version Model NumberVT-1205-01-E
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
GS100385640026925 [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 Date2017-01-26

On-Brand Devices [na]

00385640033718J-1084A
00385640033701J-1084
00385640029490OM-1001-MM
00385640029483OM-1000-MM
00385640029476OM-1000-BR
00385640028790SM-45208
00385640028783OM-1000-SN
003856400283180205001
00385640028028ET-SPDT-40T
00385640027526VC-49152
00385640027489OM-1000-OS
00385640027472OM-1000-MA
00385640027465OM-4544-KR
00385640027458OM-6223-GI
00385640027441OM-1000-GM
00385640027434OM-6105-GI
00385640027427OM-4631-GI
00385640027410OM-1002-TE
00385640027403OM-4003-FX
00385640027397OM-4000-FX
00385640027380OM-2002-FX
00385640027373OM-2682-TN
00385640027359OM-1013-AE
00385640027342OM-1012-AE
00385640027335OM-1000-EY
00385640027328OM-1006-TE
00385640027151PRO-000-411
00385640027137PRO-000-410
00385640027120PRO-000-311
00385640027021OM-1007-TE
00385640027007OM-4624-GI
00385640026963OM-4600-IN
00385640026956VT-0507-01-P
00385640026949VT-0300-01-P
00385640026925VT-1205-01-E
00385640026918VT-1204-01-P
00385640026901VT-1207-01-P
00385640026895VT-1035-01-P
00385640026888VT-1001-01-P
00385640026864VT-0903-01-P
00385640026857VT-0901-01-P
00385640026840VT-0803-01-P
00385640026833VT-0803-01-E
00385640026826VT-0805-01-E
00385640026819VT-0503-01-P
00385640026772VT-0501-01-P
00385640026758VT-0500-01-P
00385640026741VT-0407-01-E
00385640026734VT-0405-01-P
00385640026727VT-0403-01-P

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