SynFix SD03802431

GUDID H981SD038024310

NON-RETAINING T15 SYNFIX DRIVER

Synthes GmbH

Surgical screwdriver, reusable

• Primary Device ID: H981SD038024310
• NIH Device Record Key: 45781ccf-e1df-4a19-b8f9-d122b90da18e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynFix
• Version Model Number: SD03.802.431
• Catalog Number: SD03802431
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034703688 [Primary]
HIBCC	H981SD038024310 [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

[H981SD038024310]

Moist Heat or Steam Sterilization

[H981SD038024310]

Moist Heat or Steam Sterilization

[H981SD038024310]

Moist Heat or Steam Sterilization

[H981SD038024310]

Moist Heat or Steam Sterilization

[H981SD038024310]

Moist Heat or Steam Sterilization

[H981SD038024310]

Moist Heat or Steam Sterilization

[H981SD038024310]

Moist Heat or Steam Sterilization

[H981SD038024310]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-07-14
• 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