SynFix 03802431

GUDID H981038024310

TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN

Synthes GmbH

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: H981038024310
• NIH Device Record Key: 24e1b11c-e145-40ae-a049-211454f9402f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynFix
• Version Model Number: 03.802.431
• Catalog Number: 03802431
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034722436 [Primary]
HIBCC	H981038024310 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072253

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

[H981038024310]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-04-26
• Device Publish Date: 2015-09-14

On-Brand Devices [SynFix]

• H981038024310: TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
• H981SD3971670: SYNFIX-LR TRIAL RASP 12DEG DEPTH 26MM/W 32MM/H 14MM
• H981SD3971650: SYNFIX-LR TRIAL RASP 12DEG DEPTH 26MM/W 32MM/H 11MM
• H981SD3971630: SYNFIX-LR TRIAL RASP 8DEG DEPTH 26MM/W 32MM/H 14MM
• H981SD3971610: SYNFIX-LR TRIAL RASP 8DEG DEPTH 26MM/W 32MM/H 11MM
• H981SD3970760: SYNFIX-LR TRIAL RASP 12DEG DEPTH 30MM/W 38MM/H 17MM
• H981SD3970750: SYNFIX-LR TRIAL RASP 12DEG DEPTH 30MM/W 38MM/H 15MM
• H981SD3970740: SYNFIX-LR TRIAL RASP 12DEG DEPTH 30MM/W 38MM/H 13.5MM
• H981SD3970730: SYNFIX-LR TRIAL RASP 12DEG DEPTH 30MM/W 38MM/H 12MM
• H981SD3970720: SYNFIX-LR TRIAL RASP 8DEG DEPTH 30MM/W 38MM/H 17MM
• H981SD3970710: SYNFIX-LR TRIAL RASP 8DEG DEPTH 30MM/W 38MM/H 15MM
• H981SD3970700: SYNFIX-LR TRIAL RASP 8DEG DEPTH 30MM/W 38MM/H 13.5MM
• H981SD3970690: SYNFIX-LR TRIAL RASP 8DEG DEPTH 30MM/W 38MM/H 12MM
• H981SD3970680: SYNFIX-LR TRIAL RASP 12DEG DEPTH 26MM/W 32MM/H 17MM
• H981SD3970670: SYNFIX-LR TRIAL RASP 12DEG DEPTH 26MM/W 32MM/H 15MM
• H981SD3970660: SYNFIX-LR TRIAL RASP 12DEG DEPTH 26MM/W 32MM/H 13.5MM
• H981SD3970650: SYNFIX-LR TRIAL RASP 12DEG DEPTH 26MM/W 32MM/H 12MM
• H981SD3970640: SYNFIX-LR TRIAL RASP 8DEG DEPTH 26MM/W 32MM/H 17MM
• H981SD3970630: SYNFIX-LR TRIAL RASP 8DEG DEPTH 26MM/W 32MM/H 15MM
• H981SD3970620: SYNFIX-LR TRIAL RASP 8DEG DEPTH 26MM/W 32MM/H 13.5MM
• H981SD3970610: SYNFIX-LR TRIAL RASP 8DEG DEPTH 26MM/W 32MM/H 12MM
• H981SD038030100: DETACHABLE AIMING DEVICE HANDLE FOR SYNFIX
• H981SD038022300: SYNFIX DRILL WITH HANDLE-3.0MM
• H981SD038022290: SYNFIX TAMP
• H981SD038022000: SYNFIX MINI-OPEN DETACHABLE AIMING DEVICE T15 SHAFT
• 10705034821092: SYNFIX EVOLUTION U-JOINT DRILL
• 10705034819457: SYNFIX EVOLUTION STRAIGHT AWL
• 10705034818337: SYNFIX EVOLUTION U-JOINT AWL ASSEMBLY
• H981SD038022010: EXTENDED SYNFIX MINI-OPEN IMPLANT COUPLING
• H981SD038024340: T15 SYNFIX DRIVER 40 DEGREE DOUBLE WOBBLE
• H981SD038024310: NON-RETAINING T15 SYNFIX DRIVER
• H981SD038023310: DRIVER FOR SYNFIX MINI-OPEN SHORT TIP