Duns Number:079375431
Device Description: 6mL Oral Syringe Orange Sterile
Catalog Number
NM-S6EO
Brand Name
NEOMED*
Version/Model Number
NM-S6EO
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
-
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
d11bcecb-deb7-415e-a468-41a45f3f7e8f
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
May 13, 2021
Package DI Number
10350770002597
Quantity per Package
200
Contains DI Package
00350770002590
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 269 |
2 | A medical device with a moderate to high risk that requires special controls. | 5221 |