Duns Number:094651270
Device Description: SYRINGE,NUTRI-LOK 60mL LOCKING ORAL DOSE
Catalog Number
41560
Brand Name
NUTRI-LOK
Version/Model Number
Oral Dispensing Syringes
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KYX
Product Code Name
Dispenser, Liquid Medication
Public Device Record Key
f46bb09f-a67d-4e32-a95e-139bd2367db3
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
June 04, 2020
Package DI Number
H671415601
Quantity per Package
50
Contains DI Package
H671415600
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |