Duns Number:421335278
Device Description: Theproducts have two types, common type and safety type. Both of the two types are sterile Theproducts have two types, common type and safety type. Both of the two types are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type hasseveral models. Different models are distinguished by needle gauge and length.The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and thesilicone oil is used to needle tube lubrication.The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needlehub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle huband the silicone oil is used to needle tube lubrication.The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needleis designed to reduce occurrence of accidental needle sticks from patient end of the needle byproviding a shield that covers and locks the needle after use. As the user proceeds with inserting theneedle into the skin the shield will retract. After the injection is completed and needle is removedfrom the skin, the shield will automatically extend to cover the needle and lock in place. Once theSafety Type Insulin Pen Needle is in the locked mode, it can no longer be used.Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, andthey are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1.
Catalog Number
-
Brand Name
Verifine ® Common Type Insulin Pen Needle
Version/Model Number
IPN-32-4
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Product Code Name
-
Public Device Record Key
4ad8a9a9-abf8-43c0-b077-091ca614c637
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 25, 2017
Package DI Number
56971227400067
Quantity per Package
50
Contains DI Package
36971227400063
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |