SD03010531

GUDID 10886982347473

CENTERING SLEEVE

Synthes GmbH

Orthopaedic trocar blade, reusable

• Primary Device ID: 10886982347473
• NIH Device Record Key: 9af5443b-ae66-4d53-acb0-aa8af8fa812b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD03.010.531
• Catalog Number: SD03010531
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982347473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111667

FDA Product Code

• JDS: NAIL, FIXATION, BONE

Sterilization

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

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

[10886982347473]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-02
• Device Publish Date: 2024-07-25

Devices Manufactured by Synthes GmbH

• 10887587078434 - NA: 2025-07-03 REDUCTION FORCEPS W/ POINTS
• 10886982343994 - NA: 2025-07-01 Ø14MM HOLLOW REAMER - FRN
• 07611819642669 - NA: 2025-06-27 130 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
• 07611819642676 - NA: 2025-06-27 125 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
• 07611819655522 - NA: 2025-06-27 135 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
• 10886982348159 - NA: 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER
• 10886982348166 - NA: 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/250MM/HA STER
• 10886982348173 - NA: 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/175MM/HA STER