PROCAM FULL PAL - PROCAM FULL PAL - Ecleris

Duns Number:043555079

Device Description: PROCAM FULL PAL

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

U1VI3111

Brand Name

PROCAM FULL PAL

Version/Model Number

R00

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

FWF

Product Code Name

Camera, Television, Endoscopic, Without Audio

Device Record Status

Public Device Record Key

ac1b133d-30dd-4d8e-bc55-b1329249b6e4

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ECLERIS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 62
2 A medical device with a moderate to high risk that requires special controls. 25