Duns Number:007914906
Device Description: 4mm Pen Needle UltiGuard
Catalog Number
-
Brand Name
GNP
Version/Model Number
09543GNP
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100812,K100812,K100812
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
34c90461-8060-4f4a-bb02-dbbb13d54b84
Public Version Date
August 08, 2022
Public Version Number
2
DI Record Publish Date
January 28, 2022
Package DI Number
00087701434273
Quantity per Package
1
Contains DI Package
00087701434310
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
UltiGuard
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |