Duns Number:094651270
Device Description: SYRINGE,NUTRI-LOK 1 ML LOCKING ORAL DISPENSING
Catalog Number
41501
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
63fc1fe2-a978-4c19-9f64-3df922275263
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
June 04, 2020
Package DI Number
H671415011
Quantity per Package
100
Contains DI Package
H671415010
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 |