240019

GUDID H6792400190

3.5MM/4.5MM WASHER

Synthes GmbH

Orthopaedic bone washer, non-sterile

• Primary Device ID: H6792400190
• NIH Device Record Key: 47d94d03-02fe-45b1-872b-0e45068c9e53
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 240.019
• Catalog Number: 240019
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982164407 [Primary]
HIBCC	H6792400190 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983787

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

[H6792400190]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-29
• Device Publish Date: 2015-09-14

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• 10886982349873 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 16MM
• 10886982349880 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 18MM
• 10886982349897 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 20MM
• 10886982349903 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 22MM
• 10886982350039 - NA: 2025-08-15 CRE DRILL GUIDE 15MM
• 10886982350046 - NA: 2025-08-15 CRE DRILL GUIDE 18MM