SD800541

GUDID 10887587066004

PSI SD800.541 PEEK IMPLANT

SYNTHES (U.S.A.) LP

Cranial bone prosthesis, custom-made

• Primary Device ID: 10887587066004
• NIH Device Record Key: 3b6c6095-8f6a-41dc-8d96-4273e5df1686
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD800.541
• Catalog Number: SD800541
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: 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
• 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	10887587066004 [Primary]
HIBCC	H980SD8005410 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033868

FDA Product Code

• GXN: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Sterilization

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

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

Moist Heat or Steam Sterilization

[10887587066004]

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: 2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

• 10886982293060 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25
• 10886982293237 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
• 10886982293244 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25
• 10886982293251 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 34MM/ XL25
• 10886982293268 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25
• 10886982293275 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25
• 10886982293282 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25
• 10886982293299 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25