Duns Number:361663839
Device Description: SYR U100 1cc 29x.5
Catalog Number
-
Brand Name
Syringes Safety
Version/Model Number
11466
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
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
-
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
1ffd79dc-043f-4d81-8d35-f4004e24b1e7
Public Version Date
June 10, 2019
Public Version Number
1
DI Record Publish Date
June 01, 2019
Package DI Number
20369771000898
Quantity per Package
5
Contains DI Package
10369771000891
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 23 |