Catalog Number

DBANM1104TL

Brand Name

Bone Access Needle

Version/Model Number

DBANM1104TL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

-

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

432c0cc9-0d75-4778-a176-8c04d7dff6a1

Public Version Date

September 01, 2020

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20886333222951

Quantity per Package

10

Contains DI Package

00886333222957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box