Becker® - EDMS 27873 BECKR W/SC BLW DC W/NLESS INJ - MEDTRONIC PS MEDICAL, INC.

Duns Number:089055867

Device Description: EDMS 27873 BECKR W/SC BLW DC W/NLESS INJ

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More Product Details

Catalog Number

-

Brand Name

Becker®

Version/Model Number

27873

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

GWM

Product Code Name

Device, monitoring, intracranial pressure

Device Record Status

Public Device Record Key

e626d5d4-3a6d-416c-a6c2-8e00f5cb4878

Public Version Date

April 20, 2020

Public Version Number

1

DI Record Publish Date

April 12, 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