neoWave Lumbar, Straight LS1-A1-002016

GUDID 00840493416434

Paddle Shaver, 16mm

XENIX MEDICAL LLC

Bone file/rasp, manual, reusable
Primary Device ID00840493416434
NIH Device Record Key20c94f35-dfdc-47cc-996d-65e31258ca46
Commercial Distribution StatusIn Commercial Distribution
Brand NameneoWave Lumbar, Straight
Version Model NumberLS1-A1-002016
Catalog NumberLS1-A1-002016
Company DUNS080386764
Company NameXENIX MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840493416434 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840493416434]

Moist Heat or Steam Sterilization

[00840493416434]

Moist Heat or Steam Sterilization

[00840493416434]

Moist Heat or Steam Sterilization

[00840493416434]

Moist Heat or Steam Sterilization

[00840493416434]

Moist Heat or Steam Sterilization

[00840493416434]

Moist Heat or Steam Sterilization

[00840493416434]

Moist Heat or Steam Sterilization

[00840493416434]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-24
Device Publish Date2026-03-16

On-Brand Devices [neoWave Lumbar, Straight]

00840493416434Paddle Shaver, 16mm
00840493416427Paddle Shaver, 15mm
00840493416410Paddle Shaver, 14mm
00840493416403Paddle Shaver, 13mm
00840493416397Paddle Shaver, 12mm
00840493416380Paddle Shaver, 11mm
00840493416373Paddle Shaver, 10mm
00840493416366Paddle Shaver, 9mm
00840493416359Paddle Shaver, 8mm
00840493416342Paddle Shaver, 7mm
00840493416335Paddle Shaver, 6mm
00840493416328Paddle Distractor, 16mm
00840493416311Paddle Distractor, 15mm
00840493416304Paddle Distractor, 14mm
00840493416298Paddle Distractor, 13mm
00840493416281Paddle Distractor, 12mm
00840493416274Paddle Distractor, 11mm
00840493416267Paddle Distractor, 10mm
00840493416250Paddle Distractor, 9mm
00840493416243Paddle Distractor, 8mm
00840493416236Paddle Distractor, 7mm
00840493416229Paddle Distractor, 6mm
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