Slings - SLING, COMFORT, DISP, LG - JOERNS HEALTHCARE, LLC

Duns Number:790937150

Device Description: SLING, COMFORT, DISP, LG

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More Product Details

Catalog Number

NA25613

Brand Name

Slings

Version/Model Number

NA25613

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

0ac984ab-e727-4197-ac69-344392257af2

Public Version Date

January 31, 2022

Public Version Number

1

DI Record Publish Date

January 23, 2022

Additional Identifiers

Package DI Number

20810055882100

Quantity per Package

10

Contains DI Package

00810055882106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"JOERNS HEALTHCARE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 164
2 A medical device with a moderate to high risk that requires special controls. 131