Duns Number:783518983
Device Description: (1/2cc)(5/16")(31G) Single use disposable insulin syringes. Includes 100 sterile needles i (1/2cc)(5/16")(31G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.
Catalog Number
-
Brand Name
True Comfort Pro Insulin Syringes 31G 1/2CC 5/16"
Version/Model Number
INS0531-0516
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
4271f32d-eb5b-4396-86cc-93c606300560
Public Version Date
April 01, 2021
Public Version Number
1
DI Record Publish Date
March 24, 2021
Package DI Number
10850027494101
Quantity per Package
20
Contains DI Package
00850027494104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |