Duns Number:421335278
Device Description: The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and The products 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 products 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
CareTouch
Version/Model Number
IPN-29-12
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
fe68f1ef-2ada-457a-9535-924e87c3eca0
Public Version Date
August 08, 2022
Public Version Number
1
DI Record Publish Date
July 30, 2022
Package DI Number
16971227408720
Quantity per Package
50
Contains DI Package
06971227408723
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 |