Excella II® - SST - Innovasis, Inc.

Duns Number:156567492

Device Description: SST

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More Product Details

Catalog Number

LS-072

Brand Name

Excella II®

Version/Model Number

LS-072

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)

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

HXB

Product Code Name

Probe

Device Record Status

Public Device Record Key

aed72431-a722-4a67-b239-4b7f79a52256

Public Version Date

September 07, 2018

Public Version Number

1

DI Record Publish Date

August 07, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOVASIS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 252
2 A medical device with a moderate to high risk that requires special controls. 2102