Perceval S Single Use MICS Accessory Kit - SORIN GROUP ITALIA SRL

Duns Number:428011907

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More Product Details

Catalog Number

-

Brand Name

Perceval S Single Use MICS Accessory Kit

Version/Model Number

ICV1351

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

Yes

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

50679fb7-71a8-46b0-be5b-95bea5fa9f5e

Public Version Date

July 04, 2022

Public Version Number

6

DI Record Publish Date

June 06, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SORIN GROUP ITALIA SRL" 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. 398
3 A medical device with high risk that requires premarket approval 78