SURECAN SAFETY II - Surecan™ Safety II Port Access Needle Set 19G x - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: Surecan™ Safety II Port Access Needle Set 19G x 0.8in. (20mm)

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More Product Details

Catalog Number

4447001-02

Brand Name

SURECAN SAFETY II

Version/Model Number

4447001-02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

PTI

Product Code Name

Non-Coring (Huber) Needle

Device Record Status

Public Device Record Key

5bc82480-f4b1-4674-9137-408b32364706

Public Version Date

March 03, 2020

Public Version Number

8

DI Record Publish Date

December 22, 2017

Additional Identifiers

Package DI Number

04046964999727

Quantity per Package

5

Contains DI Package

04046955156245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"B. BRAUN MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 277
U Unclassified 2