Catalog Number

-

Brand Name

Ball Nose Guide Wire, 2.0mm x 800mm

Version/Model Number

0103-800S

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

d25cfc88-8057-45d4-9861-f36d36cbdd40

Public Version Date

April 27, 2021

Public Version Number

4

DI Record Publish Date

July 24, 2015

Package DI Number

00848665039313

Quantity per Package

5

Contains DI Package

00848665000085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box