SaveFine ® Insulin Pen Needle - Theproducts have two types, common type and - Promisemed Hangzhou Meditech Co., Ltd.

Duns Number:421335278

Device Description: Theproducts have two types, common type and safety type. Both of the two types are sterile

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

SaveFine ® Insulin Pen Needle

Version/Model Number

IPN-32-8

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

3b5d762d-63f8-4a9b-b331-8f4d50f3b037

Public Version Date

April 04, 2019

Public Version Number

1

DI Record Publish Date

March 27, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROMISEMED HANGZHOU MEDITECH CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1