FISSO - FISSO Fastening Straps black. Includes 2 straps, - Baitella AG

Duns Number:484942081

Device Description: FISSO Fastening Straps black. Includes 2 straps, Art.: 93.285

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More Product Details

Catalog Number

5.890

Brand Name

FISSO

Version/Model Number

5.890-VE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2022

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

FWZ

Product Code Name

Operating Room Accessories Table Tray

Device Record Status

Public Device Record Key

db3c01ca-31ab-47a0-b216-da76b16a1ebb

Public Version Date

May 02, 2022

Public Version Number

3

DI Record Publish Date

October 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BAITELLA AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 1