neoWave LS N/A

GUDID 00818345027961

Lumbar Inserter, PLIF, 7-10H

HT MEDICAL, LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00818345027961
NIH Device Record Keyc0db5ef5-5cab-4359-bc33-8c64c9ec3093
Commercial Distribution StatusIn Commercial Distribution
Brand NameneoWave LS
Version Model Number23-K01-0501
Catalog NumberN/A
Company DUNS080386764
Company NameHT MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100818345027961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

[00818345027961]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-29
Device Publish Date2022-08-19

On-Brand Devices [neoWave LS]

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