MEDPOR 92-8333

GUDID 07613327424027

Ear Base Extended-Modified Design- Left

Stryker Leibinger GmbH & Co. KG

Ear prosthesis

Primary Device ID	07613327424027
NIH Device Record Key	be402d78-059e-4820-9b31-eb4b72c726de
Commercial Distribution Status	In Commercial Distribution
Brand Name	MEDPOR
Version Model Number	92-8333
Catalog Number	92-8333
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter
Width	37.9 Millimeter
Length	59.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327424027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K922489

FDA Product Code

FWP	PROSTHESIS, CHIN, INTERNAL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-06-25
Device Publish Date	2018-05-25

On-Brand Devices [MEDPOR]

07613327424027	Ear Base Extended-Modified Design- Left
07613327424010	Ear Base Extended-Modified Design- Right
07613327300482	MEDPOR CUSTOMIZED-PLUS-XL
07613327300468	MEDPOR CUSTOMIZED-PLUS-M
07613327300420	MEDPOR CUSTOMIZED-PLUS-L
07613327300390	MEDPOR CUSTOMIZED-PLUS-S
07613327292336	Nostril Retainer Asymmetric - R4-L3
07613327292329	Nostril Retainer Asymmetric - R2-L1
07613327292312	Nostril Retainer Symmetric - R3-L3
07613327292305	Nostril Retainer Asymmetric - R3-L2
07613327292299	Nostril Retainer Symmetric - R1-L1
07613327292282	Nostril Retainer Asymmetric - R1-L2
07613327292275	Nostril Retainer Asymmetric - R3-L4
07613327292268	Nostril Retainer Symmetric - R2-L2
07613327292251	Nostril Retainer Symmetric - R4-L4
07613327292244	Nostril Retainer Asymmetric - R2-L3
07613327089745	Chin Extended Square RZ - 3mm
07613327089738	Chin Extended Square RZ - 5mm
07613327089721	Chin Extended Square RZ - 7mm
07613327089714	Chin Extended Round RZ-5mm
07613327089707	Chin Extended Round RZ-7mm
07613327089691	Chin Extended Round RZ-3mm
07613252714132	EAR BASE EXTENDED - Reinisch Design - Left
07613252714125	EAR BASE EXTENDED - Reinisch Design - Right
07613252615811	Midface Contour Implant - Reconstructive - Right with Sizing Template
07613252615804	Midface Contour Implant - Reconstructive - Left with Sizing Template
07613252508670	Pterional-Right-SMOOTH
07613252508526	Pterional-Left-SMOOTH
07613252457671	5444-0-611 Mandible Implant (2) / 5444-0-112 Host Bone (1)
07613252457664	5444-0-411 X-Large Implant (2) / 5444-0-112 Host Bone (1)
07613252457657	5444-0-511 Midface Implant (2) / 5444-0-112 Host Bone (1)
07613252457640	5444-0-311 Large Implant (2) / 5444-0-112 Host Bone (1)
07613252457633	5444-0-211 Medium Implant (2) / 5444-0-112 Host Bone (1)
07613252457626	5444-0-111 Small Implant (2) / 5444-0-112 Host Bone (1)
07613252170297	Malar Implant Teardrop Standard
07613252088790	Mandibular Angle RZ Large - Right 11mm L.P.
07613252088783	Malar Extended Contoured - Medium Left
07613252088776	Inferior Orbital Rim - Right
07613252088769	Inferior Orbital Rim - Left
07613252088745	Button Chin ? Large
07613252088738	Button Chin ? Small
07613252088721	Pet Nasal Dors Sizer Set (Sil Non-Ster)
07613252088714	Petite Nasal Dorsum
07613252088707	Petite Nasal Dorsum
07613252088691	Petite Nasal Dorsum
07613252088684	Petite Nasal Dorsum
07613252088677	Sheet - Micro Thin 0.35mm
07613252088660	Midface Rim-Left
07613252088585	MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
07613252088578	MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter

Trademark Results [MEDPOR]

Mark Image Registration \| Serial	Company Trademark Application Date
MEDPOR 73531578 1361692 Live/Registered	POREX TECHNOLOGIES CORP. OF GEORGIA 1985-04-10