Duns Number:051957769
Device Description: Sterile, single-use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length, extra-thin wall
Catalog Number
-
Brand Name
Relion Pen Needles
Version/Model Number
700014718
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"
-
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
7b6480d0-c1e8-4a9a-aed8-a582a0ea1231
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
March 01, 2019
Package DI Number
20681131023133
Quantity per Package
40
Contains DI Package
00681131023139
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |