SOLIDEA - RELAX UNISEX CCL.1 PLUS LINE, SIZE XL, NERO, - CALZIFICIO PINELLI SRL

Duns Number:431221795

Device Description: RELAX UNISEX CCL.1 PLUS LINE, SIZE XL, NERO, GRADUATED COMPRESSION 18/21 mmHg KNEE-HIGH

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More Product Details

Catalog Number

0545A8

Brand Name

SOLIDEA

Version/Model Number

57192

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

DWL

Product Code Name

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Device Record Status

Public Device Record Key

8f4ddb51-e41a-41c2-b901-e2c972ec4948

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

November 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CALZIFICIO PINELLI SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2515
2 A medical device with a moderate to high risk that requires special controls. 751