Catalog Number

BFCS000304

Brand Name

Adler MicroMed Laser Surgery Fiber

Version/Model Number

BFCS000304

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

K152417,K152417,K152417

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

49934097-1ae9-4659-b7cf-1a5e36b7b444

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

December 05, 2018

Package DI Number

00850348007298

Quantity per Package

10

Contains DI Package

00850348007274

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-