SP-78105

GUDID 00385640000017

SUMMIT MEDICAL, INC.

Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable
Primary Device ID00385640000017
NIH Device Record Keyc1ff5bef-8436-4a64-8773-2061f017fb24
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSP-78105
Catalog NumberSP-78105
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100385640000017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFBButton, Nasal Septal

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

[00385640000017]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-10
Device Publish Date2016-06-06

Devices Manufactured by SUMMIT MEDICAL, INC.

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00385640017954 - INSTRUSAFE2024-04-22
00385640080712 - INSTRUSAFE2024-04-19
00385640080729 - INSTRUSAFE2024-04-19
00385640080736 - INSTRUSAFE2024-04-19
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