AbsorbENT Sinus Pack RH-7530-10

GUDID 00385640000482

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
Primary Device ID00385640000482
NIH Device Record Key9b377199-4c0f-40f1-b32e-ab158afde6d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbsorbENT Sinus Pack
Version Model NumberRH-7530-10
Catalog NumberRH-7530-10
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100385640000482 [Primary]
GS110385640000489 [Package]
Package: SHELF BOX [10 Units]
In Commercial Distribution

FDA Product Code

LYASplint, Intranasal Septal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2016-08-17

On-Brand Devices [AbsorbENT Sinus Pack]

00385640000499RH-7532-10
00385640000482RH-7530-10

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