Zyppah ZCA-100-03

GUDID 00866868000305

Hybrid oral appliance, camouflage version

A.M.A. PLASTICS

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID00866868000305
NIH Device Record Key63438da0-b571-4f3b-bbb3-34f4d6eccff0
Commercial Distribution StatusIn Commercial Distribution
Brand NameZyppah
Version Model NumberCamouflage
Catalog NumberZCA-100-03
Company DUNS064454531
Company NameA.M.A. PLASTICS
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

Phone800-875-3370
Emailwecare@zyppah.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100866868000305 [Primary]

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-01-10

On-Brand Devices [Zyppah]

00866868000381Edge to Edge
00866868000343Hybrid oral appliance, red / white / blue version
00866868000336Hybrid oral appliance, marbled pink / pink / white version
00866868000329Hybrid oral appliance, pink version
00866868000312Hybrid oral appliance, grey / green version
00866868000305Hybrid oral appliance, camouflage version

Trademark Results [Zyppah]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZYPPAH
ZYPPAH
85471173 4269506 Live/Registered
Jonathan Greenburg, DDS
2011-11-12

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