PYRAMID MKII: SODA LIME ABSORBER SHERASORB W/V - PYRAMID MKII: SODA LIME ABSORBER SHERASORB W/V - Intersurgical Incorporated

Duns Number:785952607

Device Description: PYRAMID MKII: SODA LIME ABSORBER SHERASORB W/V

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


More Product Details

Catalog Number

-

Brand Name

PYRAMID MKII: SODA LIME ABSORBER SHERASORB W/V

Version/Model Number

2191001

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

BSF

Product Code Name

Absorber, Carbon-Dioxide

Device Record Status

Public Device Record Key

b16eac0e-b426-403e-9a02-c1828126646e

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 28, 2021

Additional Identifiers

Package DI Number

05030267117031

Quantity per Package

6

Contains DI Package

05030267117024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INTERSURGICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 101