Handi-Move Sling - Amputationsling (2 legs) Daylite Fabric ; hygiene - Handi-Move

Duns Number:283658730

Device Description: Amputationsling (2 legs) Daylite Fabric ; hygiene opening; Custom Made

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More Product Details

Catalog Number

-

Brand Name

Handi-Move Sling

Version/Model Number

3545 90000001

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

FSA

Product Code Name

Lift, patient, non-ac-powered

Device Record Status

Public Device Record Key

a929f0a6-aadb-40c2-810c-47efc375f2d9

Public Version Date

September 16, 2020

Public Version Number

1

DI Record Publish Date

September 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANDI-MOVE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 260
2 A medical device with a moderate to high risk that requires special controls. 2