MEDPOR 80014

GUDID 07613252088585

MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter

Stryker Leibinger GmbH & Co. KG

Orbital sphere implant

• Primary Device ID: 07613252088585
• NIH Device Record Key: f2995b1d-3e88-48c4-8c5c-9dd408300d36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDPOR
• Version Model Number: 80014
• Catalog Number: 80014
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252088585 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

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