Salvacel - Limb Holder with metal ring size XL - MEDI CARE SYSTEM SLU

Duns Number:511139446

Device Description: Limb Holder with metal ring size XL

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More Product Details

Catalog Number

-

Brand Name

Salvacel

Version/Model Number

SVC2476XL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

FMQ

Product Code Name

Restraint, protective

Device Record Status

Public Device Record Key

036f3411-9b95-4c8e-a8be-884905b7328e

Public Version Date

December 02, 2019

Public Version Number

1

DI Record Publish Date

November 22, 2019

Additional Identifiers

Package DI Number

08436035350438

Quantity per Package

24

Contains DI Package

08436035350421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDI CARE SYSTEM SLU" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 170