Handicare - Limb Sling 6 - HANDICARE USA, INC.

Duns Number:800145836

Device Description: Limb Sling 6

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More Product Details

Catalog Number

-

Brand Name

Handicare

Version/Model Number

400250

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

73d908fa-5261-4398-ba1e-ece1be9cb32e

Public Version Date

September 03, 2020

Public Version Number

1

DI Record Publish Date

August 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANDICARE USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 535