Pt-Snap - Pt-SnapMale part CSpare part - Cendres+Métaux SA

Duns Number:487506230

Device Description: Pt-SnapMale part CSpare part

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More Product Details

Catalog Number

051863

Brand Name

Pt-Snap

Version/Model Number

051863

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

EGG

Product Code Name

Attachment, Precision, All

Device Record Status

Public Device Record Key

2128370c-f0f1-4c71-9383-07f4b900fdce

Public Version Date

August 11, 2020

Public Version Number

1

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