Catalog Number

900.000

Brand Name

Powered Cole Isolation Device

Version/Model Number

PCID

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GEY

Product Code Name

Motor, Surgical Instrument, Ac-Powered

Public Device Record Key

7dc961ba-5b30-42ce-a6c9-c9b6264411b8

Public Version Date

February 12, 2021

Public Version Number

1

DI Record Publish Date

February 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-