CORRIDOR PILOT,JERON,1-BULB,WHITE,CREST - CORRIDOR PILOT,JERON,1-BULB,WHITE,CREST - Crest Healthcare Supply

Duns Number:151772415

Device Description: CORRIDOR PILOT,JERON,1-BULB,WHITE,CREST

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More Product Details

Catalog Number

-

Brand Name

CORRIDOR PILOT,JERON,1-BULB,WHITE,CREST

Version/Model Number

8805C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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 Details

Product Code

ILQ

Product Code Name

System, Communication, Powered

Device Record Status

Public Device Record Key

f2bc7876-d39c-4e82-ba32-a73cdaa80039

Public Version Date

October 07, 2020

Public Version Number

1

DI Record Publish Date

September 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CREST HEALTHCARE SUPPLY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 792