MEDPOR 92-82007

GUDID 07613327292053

Transsphenoidal Sellar (TSI) - Large

Stryker Leibinger GmbH & Co. KG

Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 07613327292053
• NIH Device Record Key: bdb40677-fb0d-4598-b4a7-17ab0d0d9700
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDPOR
• Version Model Number: 92-82007
• Catalog Number: 92-82007
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327292053 [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: 2021-02-23
• Device Publish Date: 2021-02-15

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