neoWave LS - Lumbar Inserter, PLIF, 7-10H - HT MEDICAL, LLC

Duns Number:080386764

Device Description: Lumbar Inserter, PLIF, 7-10H

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More Product Details

Catalog Number

N/A

Brand Name

neoWave LS

Version/Model Number

23-K01-0501

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182210

Product Code Details

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

c0db5ef5-5cab-4359-bc33-8c64c9ec3093

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HT MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 178
2 A medical device with a moderate to high risk that requires special controls. 414