Slide.fit - donning aid for transfemoral prostheses, size XL, - Streifeneder ortho.production GmbH

Duns Number:317931954

Device Description: donning aid for transfemoral prostheses, size XL, dark grey / light blue

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More Product Details

Catalog Number

17A1/XL

Brand Name

Slide.fit

Version/Model Number

17A1/XL

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)

-

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

ISY

Product Code Name

Joint, Knee, External Limb Component

Device Record Status

Public Device Record Key

65b0f3cb-ac00-4c7a-b5cd-cde0decd9b1c

Public Version Date

November 10, 2020

Public Version Number

1

DI Record Publish Date

November 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STREIFENEDER ORTHO.PRODUCTION GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 64