Clear-Site® - EDMS 46918 CLEAR-SITE LASER LEVEL - MEDTRONIC PS MEDICAL, INC.

Duns Number:089055867

Device Description: EDMS 46918 CLEAR-SITE LASER LEVEL

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More Product Details

Catalog Number

-

Brand Name

Clear-Site®

Version/Model Number

46918

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

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

K983799

Product Code Details

Product Code

GWM

Product Code Name

Device, monitoring, intracranial pressure

Device Record Status

Public Device Record Key

f9fb1046-3ca0-4cb4-ab0b-aa7aae7f1263

Public Version Date

October 17, 2022

Public Version Number

2

DI Record Publish Date

April 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC PS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 1465