03405000S

GUDID 10886982300829

RADIAL HEAD REPLACEMENT INSTRUMENT KIT, STERILE

Synthes GmbH

Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use

• Primary Device ID: 10886982300829
• NIH Device Record Key: b2615762-d8ae-48c6-be36-c41dce184d8a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.405.000S
• Catalog Number: 03405000S
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982300829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183618

FDA Product Code

• KWI: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-05-02
• Device Publish Date: 2020-06-08

Devices Manufactured by Synthes GmbH

• 10887587078359 - NA: 2024-04-16 MANDIBLE BODY REDUCTION HANDLE
• 10886982344427 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/TIBIAL FIXTN/LNG/STER
• 10886982344434 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/TIBIAL FIXTN/LNG/STER
• 10886982345745 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/LONG/STERILE
• 10886982345752 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/LONG/STERILE
• H67904038070S0 - TFN-ADVANCE: 2024-02-27 TFNA SCREW 70MM - STERILE
• H6792161400 - NA: 2024-02-27 6.5MM CANCELLOUS BONE SCREW 16MM THREAD/140MM
• H6792180750 - NA: 2024-02-27 6.5MM CANCELLOUS BONE SCREW FULLY THREADED/75MM