Duns Number:989772017
Device Description: 1ml Suresafe Manual Retractable 25G x 1" Syringe
Catalog Number
FD-MSSFX01-25
Brand Name
1ml Suresafe Manual Retractable Syringe 25G x 1"
Version/Model Number
1ml 25G x 1"
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
3b8d39cf-76fa-4811-9aae-a0c6e5b0fcea
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 06, 2017
Package DI Number
05391530750776
Quantity per Package
30
Contains DI Package
05391530750769
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 |