FCI directional LASER PROBE / EXTENDABLE 25G QUANTEL - FCI directional LASER PROBE / EXTENDABLE 25G - FCI S A S FCI 20 22

Duns Number:763408366

Device Description: FCI directional LASER PROBE / EXTENDABLE 25G QUANTEL

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More Product Details

Catalog Number

-

Brand Name

FCI directional LASER PROBE / EXTENDABLE 25G QUANTEL

Version/Model Number

S9.1323.25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HQB

Product Code Name

Photocoagulator And Accessories

Device Record Status

Public Device Record Key

4d393dbc-4dd9-49c1-a16a-1ac321cc3ab5

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 30, 2021

Additional Identifiers

Package DI Number

23700773723489

Quantity per Package

10

Contains DI Package

13700773723482

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FCI S A S FCI 20 22" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 291
U Unclassified 60