Catalog Number

ea

Brand Name

HoverSling Repositioning Sheet

Version/Model Number

RM-HMSLING-39RS-B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

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

FSA

Product Code Name

Lift, Patient, Non-Ac-Powered

Public Device Record Key

d28e75e3-1d61-42ab-94e1-d912e388561e

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 17, 2020

Package DI Number

10816317023796

Quantity per Package

5

Contains DI Package

00816317023799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case