78-80010

GUDID 07613327300048

PEEK Customized PRIORITY-PLUS-S

Stryker Leibinger GmbH & Co. KG

Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable
Primary Device ID07613327300048
NIH Device Record Keydd593409-295b-439e-8596-f5fe6a69b2ae
Commercial Distribution StatusIn Commercial Distribution
Version Model Number78-80010
Catalog Number78-80010
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327300048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWOPlate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


[07613327300048]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-04
Device Publish Date2021-01-27

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613327556285 - NA2024-02-27 Facial iD MF 1 Mesh
07613327556308 - NA2024-02-23 Facial iD MF 2 meshes
07613327556322 - NA2024-02-23 Facial iD MF 3 meshes
07613327556346 - NA2024-02-23 Facial iD MF 4 meshes
07613327556377 - NA2024-02-23 Facial iD MF 5 meshes
07613327556391 - NA2024-02-23 Facial iD MF 6 meshes
07613327556827 - NA2024-02-23 Facial iD MF 1 mesh kit
07613327556834 - NA2024-02-23 Facial iD MF 3 meshes kit

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