Duns Number:421335278
Device Description: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length.The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication.The product is 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.The products are for OTC use, and they 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
Assure® ID Safety Pen Needle
Version/Model Number
SPN-31-5
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
cde5ff32-be38-4906-9fd1-c18485fbb7f0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 12, 2018
Package DI Number
56971227400395
Quantity per Package
12
Contains DI Package
36971227400391
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 |