395685

GUDID H6793956850

SMALL EX-FIX 4.0MM T-BAR CRBN FBR ROD 80X50MM/MR-CONDITIONAL

Synthes GmbH

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: H6793956850
• NIH Device Record Key: c464a30c-3466-4c10-a2ed-1706a9ab2ed9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 395.685
• Catalog Number: 395685
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982200532 [Primary]
HIBCC	H6793956850 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050631

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

[H6793956850]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-05-02
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10886982346933 - NA: 2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA
• 10886982346957 - NA: 2024-05-08 FNS ANGLED GUIDE 130° W/ WIDER BASE
• 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