DAFILON - DAFILON BLUE 1(4)150CM HRC40S (M)LOOPDDP - B BRAUN SURGICAL SA

Duns Number:511268005

Device Description: DAFILON BLUE 1(4)150CM HRC40S (M)LOOPDDP

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More Product Details

Catalog Number

B0934001

Brand Name

DAFILON

Version/Model Number

B0934001

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

GAR

Product Code Name

Suture, nonabsorbable, synthetic, polyamide

Device Record Status

Public Device Record Key

5b27e0d6-9685-4f31-b987-c89bebe49b62

Public Version Date

May 10, 2022

Public Version Number

4

DI Record Publish Date

May 03, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B BRAUN SURGICAL SA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13