Dalbo®-S - Dalbo®-S Female part - Cendres+Métaux SA

Duns Number:487506230

Device Description: Dalbo®-S Female part

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More Product Details

Catalog Number

051514

Brand Name

Dalbo®-S

Version/Model Number

051514

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 03, 2020

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

Yes

Prescription Use (Rx)

Yes

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

EGG

Product Code Name

Attachment, Precision, All

Device Record Status

Public Device Record Key

00207796-d91d-465e-981e-cee998443fcc

Public Version Date

May 13, 2021

Public Version Number

2

DI Record Publish Date

August 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CENDRES+MÉTAUX SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 208
2 A medical device with a moderate to high risk that requires special controls. 535