02164000S

GUDID 10886982310897

3.5MM INTRAPELVIC ACET PLATE LARGE RIGHT STANDARD STERILE

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 10886982310897
• NIH Device Record Key: cccabbae-20be-4304-bec9-d6f50ff6c787
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 02.164.000S
• Catalog Number: 02164000S
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982310897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221809

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

[10886982310897]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-07
• Device Publish Date: 2022-11-29

Devices Manufactured by Synthes GmbH

• 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
• 10886982350053 - NA: 2025-08-15 CRE DRILL GUIDE 20MM
• 10886982350060 - NA: 2025-08-15 CRE DRILL GUIDE 25MM