N/A BL-2001

GUDID 00385640000734

SUMMIT MEDICAL, INC.

Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable Tympanotomy knife, reusable
Primary Device ID00385640000734
NIH Device Record Key4ac9278e-dc3a-4dc8-b2d7-0c067eb0366b
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberBL-2001
Catalog NumberBL-2001
Company DUNS965484699
Company NameSUMMIT MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Customer Support Contacts

Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com
Phone888-229-2875
Emailcustomerservice@summitmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100385640000734 [Primary]
GS110385640000731 [Package]
Package: Box [6 Units]
In Commercial Distribution

FDA Product Code

KDCInstrument, Surgical, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-22
Device Publish Date2016-08-15

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

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