412 P37,R3,2L,STANDARD,STKR - 412 P37,R3,2L,STANDARD,STKR - CURBELL MEDICAL PRODUCTS, INC.

Duns Number:796452311

Device Description: 412 P37,R3,2L,STANDARD,STKR

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More Product Details

Catalog Number

26348

Brand Name

412 P37,R3,2L,STANDARD,STKR

Version/Model Number

521209900105

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ILQ

Product Code Name

System, Communication, Powered

Device Record Status

Public Device Record Key

eb429454-e81c-420d-8be1-b1701da698c8

Public Version Date

October 15, 2020

Public Version Number

1

DI Record Publish Date

October 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CURBELL MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 478
2 A medical device with a moderate to high risk that requires special controls. 8062