56-25001

GUDID 04546540373991

TEMPORARY CONDYLAR PROSTHESIS, LEFT

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 04546540373991
• NIH Device Record Key: a215c31c-4e69-4dd9-b73b-98ef8b114c34
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 56-25001
• Catalog Number: 56-25001
• 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: 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 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 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	04546540373991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133285

FDA Product Code

• NEI: Prosthesis, condyle, mandibular, temporary

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

Moist Heat or Steam Sterilization

[04546540373991]

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: 2015-09-24

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 07613327651058 - NA: 2024-11-20 T-plate malleable left
• 07613327651065 - NA: 2024-11-20 T-plate malleable right
• 07613327651072 - NA: 2024-11-20 T-plate malleable left
• 07613327651089 - NA: 2024-11-20 T-plate malleable right
• 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