iFIX - short-term patient stabilization device - iSYS Medizintechnik GmbH

Duns Number:300207996

Device Description: short-term patient stabilization device

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More Product Details

Catalog Number

39775

Brand Name

iFIX

Version/Model Number

Slot Adapter Wing 3.0/30

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

-

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

FMQ

Product Code Name

Restraint, Protective

Device Record Status

Public Device Record Key

62cf4c0f-a0b0-4927-ba99-98dc8b7f5437

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

November 08, 2019

Additional Identifiers

Package DI Number

49010279000426

Quantity per Package

2

Contains DI Package

29010279000422

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box

"ISYS MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11