Handi-Move Slide - Handi maxicover padded - Handi-Move

Duns Number:283658730

Device Description: Handi maxicover padded

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More Product Details

Catalog Number

-

Brand Name

Handi-Move Slide

Version/Model Number

3607 00000001

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

FMR

Product Code Name

DEVICE, TRANSFER, PATIENT, MANUAL

Device Record Status

Public Device Record Key

5d8a15ed-8aa8-4000-b88b-968f07da1dde

Public Version Date

October 29, 2020

Public Version Number

1

DI Record Publish Date

October 21, 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