ACCESSORY TRAY - SORIN GROUP ITALIA SRL

Duns Number:428011907

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More Product Details

Catalog Number

-

Brand Name

ACCESSORY TRAY

Version/Model Number

ICV1230

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

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DWS

Product Code Name

INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Device Record Status

Public Device Record Key

a97cb8c4-485f-458b-a15e-267b7788f147

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

April 01, 2021

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