N/A

GUDID 00385640023566

SUMMIT MEDICAL, INC.

Instrument tray
Primary Device ID00385640023566
NIH Device Record Key37999451-7510-47db-badb-381fc69e575e
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberVC-49121
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
GS100385640023566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTube, Tympanostomy
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 Date2019-10-23
Device Publish Date2019-10-15

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.