Catalog Number

HOL200SBT

Brand Name

Dornier MedTech

Version/Model Number

Slim 270 Micron Ball Tip Single Use

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

K161771,K161771

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

c1d0bafc-fe16-4167-9c4d-4316d2c6271c

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 10, 2018

Package DI Number

00810116020324

Quantity per Package

3

Contains DI Package

00810116020331

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box