HSW SOFT-JECT® - HSW SOFT-JECT® 1,8 ML US - Henke-Sass, Wolf GmbH

Duns Number:317326411

Device Description: HSW SOFT-JECT® 1,8 ML US

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More Product Details

Catalog Number

-

Brand Name

HSW SOFT-JECT®

Version/Model Number

2103000100

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

-

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

EJI

Product Code Name

Syringe, Cartridge

Device Record Status

Public Device Record Key

9b94bd97-7ba6-466d-9f9f-b1e834ae9255

Public Version Date

December 06, 2018

Public Version Number

1

DI Record Publish Date

November 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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