TOTIM Patient Cushion Immobilization System - ESSEBI MEDICAL SRL

Duns Number:440317440

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More Product Details

Catalog Number

-

Brand Name

TOTIM Patient Cushion Immobilization System

Version/Model Number

TTM3005M CERVICAL M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

-

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

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

1194ecca-4df4-4c5b-94f8-ad5a397bd465

Public Version Date

March 16, 2020

Public Version Number

1

DI Record Publish Date

March 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ESSEBI MEDICAL SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6