TIWAVE N/A

GUDID 00818345025110

CERVICAL TRIAL, FLAT 13X12, 9MM 7° TA

HT MEDICAL, LLC

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00818345025110
• NIH Device Record Key: a06edb16-ff67-4b18-8595-3904e45042c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIWAVE
• Version Model Number: 20-TFT-3209
• Catalog Number: N/A
• Company DUNS: 080386764
• Company Name: HT MEDICAL, LLC
• 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: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818345025110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180401

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

[00818345025110]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-01
• Device Publish Date: 2020-11-23

On-Brand Devices [TIWAVE]

• 00818345026261: CERVICAL RASP, 19 X 14 X 5MM, 7°, ANATOMIC
• 00818345026254: CERVICAL RASP, 17 X 13 X 5MM, 7°, ANATOMIC
• 00818345026247: CERVICAL RASP, 15 X 12 X 5MM, 7°, ANATOMIC
• 00818345026230: CERVICAL RASP, 13 X 12 X 5MM, 7°, ANATOMIC
• 00818345026223: CERVICAL RASP, 19 X 14 X 5MM, 7°, FLAT
• 00818345026216: CERVICAL RASP, 17 X 13 X 5MM, 7°, FLAT
• 00818345026209: CERVICAL RASP, 15 X 12 X 5MM, 7°, FLAT
• 00818345026193: CERVICAL RASP, 13 X 12 X 5MM, 7°, FLAT
• 00818345026186: TI3D CAGE, 19W X 12D X 12H, 7 DEG, FLAT
• 00818345026179: TI3D CAGE, 19W X 12D X 11H, 7 DEG, FLAT
• 00818345026162: TI3D CAGE, 19W X 12D X 10H, 7 DEG, FLAT
• 00818345026155: TI3D CAGE, 19W X 12D X 9H, 7 DEG, FLAT
• 00818345026148: TI3D CAGE, 19W X 12D X 8H, 7 DEG, FLAT
• 00818345026131: TI3D CAGE, 19W X 12D X 7H, 7 DEG, FLAT
• 00818345026124: TI3D CAGE, 19W X 12D X 6H, 7 DEG, FLAT
• 00818345026117: TI3D CAGE, 19W X 12D X 5H, 7 DEG, FLAT
• 00818345025943: TI3D CAGE, 17W X 12D X 12H, 7 DEG, FLAT
• 00818345025936: TI3D CAGE, 17W X 12D X 11H, 7 DEG, FLAT
• 00818345025929: TI3D CAGE, 17W X 12D X 10H, 7 DEG, FLAT
• 00818345025912: TI3D CAGE, 17W X 12D X 9H, 7 DEG, FLAT
• 00818345025905: TI3D CAGE, 17W X 12D X 8H, 7 DEG, FLAT
• 00818345025899: TI3D CAGE, 17W X 12D X 7H, 7 DEG, FLAT
• 00818345025882: TI3D CAGE, 17W X 12D X 6H, 7 DEG, FLAT
• 00818345025875: TI3D CAGE, 17W X 12D X 5H, 7 DEG, FLAT
• 00818345025868: TI3D CAGE, 15W X 12D X 12H, 7DEG, FLAT
• 00818345025851: TI3D CAGE, 15W X 12D X 11H, 7DEG, FLAT
• 00818345025844: TI3D CAGE, 15W X 12D X 10H, 7DEG, FLAT
• 00818345025837: TI3D CAGE, 15W X 12D X 9H, 7 DEG, FLAT
• 00818345025820: TI3D CAGE, 15W X 12D X 8H, 7 DEG, FLAT
• 00818345025813: TI3D CAGE, 15W X 12D X 7H, 7 DEG, FLAT
• 00818345025806: TI3D CAGE, 15W X 12D X 6H, 7 DEG, FLAT
• 00818345025790: TI3D CAGE, 15W X 12D X 5H, 7 DEG, FLAT
• 00818345025783: TI3D CAGE, 13W X 12D X 12H, 7 DEG, FLAT
• 00818345025776: TI3D CAGE, 13W X 12D X 11H, 7 DEG, FLAT
• 00818345025769: TI3D CAGE, 13W X 12D X 10H, 7 DEG, FLAT
• 00818345025752: TI3D CAGE, 13W X 12D X 9H, 7 DEG, FLAT
• 00818345025745: TI3D CAGE, 13W X 12D X 8H, 7 DEG, FLAT
• 00818345025738: TI3D CAGE, 13W X 12D X 7H, 7 DEG, FLAT
• 00818345025721: TI3D CAGE, 13W X 12D X 6H, 7 DEG, FLAT
• 00818345025714: TI3D CAGE, 13W X 12D X 5H, 7 DEG, FLAT
• 00818345025707: CERVICAL TRIAL, FLAT 19X14, 12MM 14° XT
• 00818345025691: CERVICAL TRIAL, FLAT 19X14, 11MM 14° XT
• 00818345025684: CERVICAL TRIAL, FLAT 19X14, 10MM 14° XT
• 00818345025677: CERVICAL TRIAL, FLAT 19X14, 9MM 14° XT
• 00818345025660: CERVICAL TRIAL, FLAT 19X14, 8MM 14° XT
• 00818345025653: CERVICAL TRIAL, FLAT 19X14, 7MM 14° XT
• 00818345025646: CERVICAL TRIAL, FLAT 19X14, 6MM 14° XT
• 00818345025639: CERVICAL TRIAL, FLAT 19X14, 5MM 14° XT
• 00818345025622: CERVICAL TRIAL, FLAT 17X13, 12MM 14° XT
• 00818345025615: CERVICAL TRIAL, FLAT 17X13, 11MM 14° XT