Duns Number:137835299
Catalog Number
-
Brand Name
Jelco
Version/Model Number
972506
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K895705,K895705,K895705
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
5a040832-907a-4813-a3b7-0065e704a77e
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
January 12, 2017
Package DI Number
10351688060488
Quantity per Package
50
Contains DI Package
00351688060481
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 104 |
2 | A medical device with a moderate to high risk that requires special controls. | 36112 |