CM LOC® - 05001325 CM LOC® Basic Set Pekkton® - Cendres+Métaux SA

Duns Number:487506230

Device Description: 05001325 CM LOC® Basic Set Pekkton®

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More Product Details

Catalog Number

05001325

Brand Name

CM LOC®

Version/Model Number

05001325

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

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

EJX

Product Code Name

Anchor, Preformed

Device Record Status

Public Device Record Key

fb8884b7-8897-442e-96be-f73354a2f847

Public Version Date

September 24, 2021

Public Version Number

6

DI Record Publish Date

June 20, 2018

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