Catalog Number

BFCS000288

Brand Name

Adler MircroMed Laser Surgery Fiber

Version/Model Number

BFCS000288

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

db2d5ee9-65bf-41ff-aa4c-5aea1a2c13a3

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 09, 2018

Package DI Number

00850348007205

Quantity per Package

10

Contains DI Package

00850348007182

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-