Duns Number:989772017
Device Description: 1ml Tuberculin Automatic Retraction Safety Syringe - 25G x 5/8" - Sterile
Catalog Number
FD-SSFX01T-25
Brand Name
1ml Tuberculin Suresafe Syringe
Version/Model Number
1ml Tuberculin Syringe - 25G x 5/8"
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141349,K141349,K141349
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
a36f80ce-c787-4f6f-b3cb-0884f5ee96b7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 11, 2016
Package DI Number
05391530750233
Quantity per Package
21
Contains DI Package
05391530750226
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |