497228

GUDID H9814972280

TI INFERIOR CRADLE-SIZE 12 220MM RADIUS

Synthes GmbH

Vertical expandable prosthetic rib system

• Primary Device ID: H9814972280
• NIH Device Record Key: ea32b30a-b49b-467b-94cc-a5c196a84a7a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 497.228
• Catalog Number: 497228
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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
• 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	10705034788029 [Primary]
HIBCC	H9814972280 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142587

FDA Product Code

• MDI: Prosthesis, rib replacement

Sterilization

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

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

[H9814972280]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-27
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10887587078427 - NA: 2025-02-28 1.85MM ORTHOGNATHIC TAP
• 10886982344410 - NA: 2025-02-26 MAXFRAME CONTROL BOX TEMPLATE
• 10886982348333 - NA: 2025-02-26 1.1MM PARALLEL WIRE GUIDE
• 10886982348364 - NA: 2025-02-26 1.4MM PARALLEL WIRE GUIDE
• 10886982348395 - NA: 2025-02-26 1.6MM PARALLEL WIRE GUIDE
• 10886982349088 - NA: 2025-02-26 TERMITE REDUCTION FORCEPS SERRATED JAW
• H6792050550 - NA: 2025-02-20 3.5MM CANNULATED SCREW PARTIALLY THREADED/55MM
• H6794089050 - NA: 2025-02-20 7.3MM TI CANNULATED SCREW 16MM THREAD/105MM