Arjo Slides Sheet - Arjo slide sheet - XL [MaxiSlide Sheet XL] - Arjohuntleigh AB

Duns Number:355804758

Device Description: Arjo slide sheet - XL [MaxiSlide Sheet XL]

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More Product Details

Catalog Number

-

Brand Name

Arjo Slides Sheet

Version/Model Number

NSAV5260

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IKX

Product Code Name

Aid, Transfer

Device Record Status

Public Device Record Key

fac9f580-9df6-4f71-8cc9-ccbed5beb9ca

Public Version Date

September 07, 2022

Public Version Number

1

DI Record Publish Date

August 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARJOHUNTLEIGH AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 420
2 A medical device with a moderate to high risk that requires special controls. 840