78-10040

GUDID 04546540730794

PEEK CUSTOMIZED CRANIAL IMPLANT KIT, XL

Stryker Leibinger GmbH & Co. KG

Cranioplasty plate, non-alterable

Primary Device ID	04546540730794
NIH Device Record Key	2237a469-99a4-4473-afa4-60cef52eff86
Commercial Distribution Status	In Commercial Distribution
Version Model Number	78-10040
Catalog Number	78-10040
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
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	false
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	04546540730794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121153

FDA Product Code

GWO	Plate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

[04546540730794]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-07-03

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613327634945 - NA	2024-10-01 Drill for 4/5mm screws SYK
07613327547429 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327547436 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327547443 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327547450 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327547467 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327547474 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327616118 - N/A	2024-08-30 Spine Guidance 5 Software

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