SPIWay SP004

GUDID 00860003136409

SPIWay Endonasal Access Guide Size Large

SPIWAY LLC

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 ID00860003136409
NIH Device Record Keyca4af77a-8ba2-4294-9590-24641d7cec4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPIWay
Version Model NumberSP004
Catalog NumberSP004
Company DUNS053144550
Company NameSPIWAY LLC
Device Count5
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com
Phone1-844-565-1226
Emailorders@spiway.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003136409 [Primary]
GS110860003136406 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYASplint, Intranasal Septal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-12
Device Publish Date2020-08-04

On-Brand Devices [SPIWay]

00860003136416SPIWay Endonasal Access Guide Size Medium
00860003136409SPIWay Endonasal Access Guide Size Large

Trademark Results [SPIWay]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIWAY
SPIWAY
85615807 4506017 Live/Registered
SPIWay LLC
2012-05-03

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