GARRETT VASCULAR DILATOR

GUDID B09927000230

GARRETT VASCULAR DILATOR

SONTEC INSTRUMENTS, INC.

Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable
Primary Device IDB09927000230
NIH Device Record Keyc6f825c3-e04b-40f2-9ff7-372bcbdc5144
Commercial Distribution StatusIn Commercial Distribution
Brand NameGARRETT VASCULAR DILATOR
Version Model Number2700-023
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone303-790-9411
Emailinfo@sontecinstruments.com
Phone303-790-9411
Emailinfo@sontecinstruments.com
Phone303-790-9411
Emailinfo@sontecinstruments.com

Device Dimensions

Length8.25 Inch
Length8.25 Inch
Length8.25 Inch
Length8.25 Inch
Length8.25 Inch
Length8.25 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896010697 [Primary]
HIBCCB09927000230 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWPDilator, Vessel, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09927000230]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09927000230]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09927000230]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
Device Publish Date2018-08-24

On-Brand Devices [GARRETT VASCULAR DILATOR]

B09927000500GARRETT VASCULAR DILATOR SOFT MALLEABLE SET OF 3
B09927000230GARRETT VASCULAR DILATOR
B09927000200GARRETT VASCULAR DILATOR SET OF 3
B09927000530GARRETT VASCULAR DILATOR
B09927000520GARRETT VASCULAR DILATOR
B09927000510GARRETT VASCULAR DILATOR
B09927000390GARRETT VASCULAR DILATOR
B09927000380GARRETT VASCULAR DILATOR
B09927000370GARRETT VASCULAR DILATOR
B09927000360GARRETT VASCULAR DILATOR
B09927000350GARRETT VASCULAR DILATOR
B09927000340GARRETT VASCULAR DILATOR
B09927000330GARRETT VASCULAR DILATOR
B09927000320GARRETT VASCULAR DILATOR
B09927000310GARRETT VASCULAR DILATOR
B09927000300GARRETT VASCULAR DILATOR SET OF 9
B09927000220GARRETT VASCULAR DILATOR
B09927000210GARRETT VASCULAR DILATOR
B0992700010P0GARRETT VASCULAR DILATOR ARROW TIP
B09927000100GARRETT VASCULAR DILATOR
B0992700009P0GARRETT VASCULAR DILATOR ARROW TIP
B09927000090GARRETT VASCULAR DILATOR
B0992700008P0GARRETT VASCULAR DILATOR ARROW TIP
B09927000080GARRETT VASCULAR DILATOR
B0992700007P0GARRETT VASCULAR DILATOR ARROW TIP
B09927000070GARRETT VASCULAR DILATOR
B0992700006P0GARRETT VASCULAR DILATOR ARROW TIP
B09927000060GARRETT VASCULAR DILATOR
B0992700005P0GARRETT VASCULAR DILATOR ARROW TIP
B09927000050GARRETT VASCULAR DILATOR
B0992700004P0GARRETT VASCULAR DILATOR ARROW TIP
B09927000040GARRETT VASCULAR DILATOR
B0992700003P0GARRETT VASCULAR DILATOR ARROW TIP
B09927000030GARRETT VASCULAR DILATOR
B0992700002P0GARRETT VASCULAR DILATOR ARROW TIP
B09927000020GARRETT VASCULAR DILATOR
B09927000010GARRETT VASCULAR DILATOR SOFT MALLEABLE SET OF 9
00192896105072Garrett Vascular Dilator Arrow Tip
00192896105065Garrett Vascular Dilator Arrow Tip
00192896105089Garrett Vascular Dilator Arrow Tip
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