390-0307

GUDID 00886385022369

Sigmoid Notch Radial Stem, Large

Stryker Trauma SA

Wrist ulna-head prosthesis Wrist ulna-head prosthesis

• Primary Device ID: 00886385022369
• NIH Device Record Key: 148891d2-0200-42e4-98eb-4ac2953b3984
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 390-0307
• Catalog Number: 390-0307
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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: false
• 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	00886385022369 [Primary]

FDA Product Code

• KXE: PROSTHESIS, WRIST, HEMI-, ULNAR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

Devices Manufactured by Stryker Trauma SA

• 04546540520388 - NA: 2024-04-19 5 STEP REFERENCE CHART DISTAL TARGETING
• 07613327614879 - VARIAX: 2024-04-19 Extended Volar DR Plate, standard, L
• 07613327614886 - VARIAX: 2024-04-19 Wrist Add-on, Top Drawer Clip
• 07613327614909 - VARIAX: 2024-04-19 Volar Distal Radius Plate Insert, Left
• 07613327614916 - VARIAX: 2024-04-19 Extended Volar DR Plate, wide, R
• 07613327614930 - VARIAX: 2024-04-19 Extended Volar DR Plate, narrow, L
• 07613327614954 - VARIAX: 2024-04-19 Volar DR Plate, standard, L
• 07613327614961 - VARIAX: 2024-04-19 Volar DR Plate, wide, R