78-10010

GUDID 04546540730763

PEEK CUSTOMIZED CRANIAL IMPLANT KIT, S

Stryker Leibinger GmbH & Co. KG

Cranioplasty plate, non-alterable

• Primary Device ID: 04546540730763
• NIH Device Record Key: 9a296271-c39c-402d-8988-3aee8f7d312d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 78-10010
• Catalog Number: 78-10010
• 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	04546540730763 [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

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

Moist Heat or Steam Sterilization

[04546540730763]

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

• 07613327634952 - NA: 2024-12-16 Drill for 6514-7-200 WL 16mm
• 07613327634969 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634976 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327634983 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634990 - NA: 2024-12-16 Drill for 6514-7-200 14mm
• 07613327635003 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327635010 - NA: 2024-12-16 Drill for 6514-7-200 WL 14mm
• 07613327651058 - NA: 2024-11-20 T-plate malleable left