Centurion - CE DRSG, SURESITE SELECT, 2.8'X3.50' - CENTURION MEDICAL PRODUCTS CORPORATION

Duns Number:017246562

Device Description: CE DRSG, SURESITE SELECT, 2.8'X3.50'

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More Product Details

Catalog Number

VAD1882-INT

Brand Name

Centurion

Version/Model Number

VAD1882-INT

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"

Yes

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

KMK

Product Code Name

DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Device Record Status

Public Device Record Key

3c74a7ea-d0e3-4860-bb2a-e856a83bc7bc

Public Version Date

August 12, 2020

Public Version Number

1

DI Record Publish Date

August 04, 2020

Additional Identifiers

Package DI Number

10653160344223

Quantity per Package

200

Contains DI Package

20653160344220

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CENTURION MEDICAL PRODUCTS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6043
2 A medical device with a moderate to high risk that requires special controls. 4077
U Unclassified 1