SURECAN SAFETY II - Surecan™ Safety II Port Access Needle Set 20G x - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: Surecan™ Safety II Port Access Needle Set 20G x 0.5in. (12mm)

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More Product Details

Catalog Number

4447043-02

Brand Name

SURECAN SAFETY II

Version/Model Number

4447043-02

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

be2151cc-2034-4fc3-83f4-8f9fd235a567

Public Version Date

March 03, 2020

Public Version Number

3

DI Record Publish Date

December 07, 2018

Additional Identifiers

Package DI Number

04046964999789

Quantity per Package

5

Contains DI Package

04046964858338

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