PLUS - PLUS support arm, 850 mm, red. Height and - Pressalit A/S

Duns Number:305656662

Device Description: PLUS support arm, 850 mm, red. Height and sideways adjustable, right hand operated, for re PLUS support arm, 850 mm, red. Height and sideways adjustable, right hand operated, for retro-fitting

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More Product Details

Catalog Number

R391485035

Brand Name

PLUS

Version/Model Number

R391485

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

ILS

Product Code Name

Adaptor, Hygiene

Device Record Status

Public Device Record Key

5f41fedd-4883-4a0a-abe8-472db81ff046

Public Version Date

June 16, 2020

Public Version Number

1

DI Record Publish Date

June 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRESSALIT A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 319