Cramer Decker Medical - Cramer Decker Medical

Duns Number:041036187

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More Product Details

Catalog Number

-

Brand Name

Cramer Decker Medical

Version/Model Number

AREG8725-B2D

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

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Device Record Status

Public Device Record Key

c6420296-006b-4a83-b207-c87d899dcd6c

Public Version Date

February 08, 2022

Public Version Number

1

DI Record Publish Date

January 31, 2022

Additional Identifiers

Package DI Number

10816505020767

Quantity per Package

20

Contains DI Package

00816505020760

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CRAMER DECKER MEDICAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12