Laser-Shield® - ENDOTRACH TUBE 7060200 LASER SHLD 5MM - MEDTRONIC XOMED, INC.

Duns Number:835465063

Device Description: ENDOTRACH TUBE 7060200 LASER SHLD 5MM

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More Product Details

Catalog Number

-

Brand Name

Laser-Shield®

Version/Model Number

7060200

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 24, 2018

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

K901016

Product Code Details

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Device Record Status

Public Device Record Key

990054b8-9ac0-41b5-be4a-cf22ab03f555

Public Version Date

March 22, 2019

Public Version Number

4

DI Record Publish Date

May 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC XOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 665
2 A medical device with a moderate to high risk that requires special controls. 1575
3 A medical device with high risk that requires premarket approval 6
U Unclassified 10