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
LotFancy
Version/Model Number
11K-2171-M
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
858729d1-36df-40cc-8017-3387ed20ae70
Public Version Date
May 29, 2020
Public Version Number
1
DI Record Publish Date
May 21, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |