neoWave LS N/A

GUDID 00818345027671

Inserter, 7-10H, Lumbar Straight

HT MEDICAL, LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00818345027671
• NIH Device Record Key: 9adbbfbb-b152-4cb9-abbf-4f863fc77eb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoWave LS
• Version Model Number: XA-INS-0710
• 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: true
• 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@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	00818345027671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182210

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

[00818345027671]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-24
• Device Publish Date: 2022-03-16

On-Brand Devices [neoWave LS]

• 00818345027688: Inserter, 11-16H, Lumbar Straight
• 00818345027671: Inserter, 7-10H, Lumbar Straight
• 00818345027985: Lumbar Inserter, Rotate, 11-16H
• 00818345027978: Lumbar Inserter, TLIF, 7-10H
• 00818345027961: Lumbar Inserter, PLIF, 7-10H
• 00818345024243: Lumbar Inserter, Inline- Lateral