68190001

GUDID 07612334228352

TRAY FOR OPERACE, 2 FROM 2

Synthes GmbH

Surgical instrument/implant rack

• Primary Device ID: 07612334228352
• NIH Device Record Key: a115cbea-6045-4759-8aee-803f63d77521
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 68.190.001
• Catalog Number: 68190001
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612334228352 [Direct Marking]
GS1	10886982338846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241927

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

[07612334228352]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-31
• Device Publish Date: 2025-07-23

Devices Manufactured by Synthes GmbH

• 07612334226747 - NA: 2025-07-31 LID 2/3 SIZE STAINLESS STEEL
• 07612334227980 - NA: 2025-07-31 TRAY FOR OPERACE, 1 FROM 2
• 07612334228352 - NA: 2025-07-31TRAY FOR OPERACE, 2 FROM 2
• 07612334228352 - NA: 2025-07-31 TRAY FOR OPERACE, 2 FROM 2
• 10886982348982 - NA: 2025-07-24 Ø12.8MM HOLLOW REAMER
• 10886982349835 - NA: 2025-07-24 WRENCH / 11MM SLOTTED SOCKET
• 10886982350121 - NA: 2025-07-24 FEMORAL GONIOMETER
• 10886982350152 - NA: 2025-07-24 5TH MET WIRE GUIDE
• 10886982350428 - NA: 2025-07-24 TENS BENDING EXTRACTOR