HSW HENKE-JECT® - HSW HENKE-JECT® 3-TLG. 5 ML BK 21G X 1 1/2 - 0,80 - Henke-Sass, Wolf GmbH

Duns Number:317326411

Device Description: HSW HENKE-JECT® 3-TLG. 5 ML BK 21G X 1 1/2 - 0,80 X 40 MM

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More Product Details

Catalog Number

5052D000V0

Brand Name

HSW HENKE-JECT®

Version/Model Number

5052D000V0

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

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

794311d2-9a3e-4b01-b237-0ee30be8f809

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Additional Identifiers

Package DI Number

04035873062875

Quantity per Package

20

Contains DI Package

04035873062868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON

"HENKE-SASS, WOLF GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 77