Duns Number:153608369
Device Description: SYRINGE TRAY 1CC LL STERILE TR50
Catalog Number
AMS1CCLL50
Brand Name
MedStream
Version/Model Number
AMS1CCLL50
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"
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
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
98d08db1-0207-48bb-9fc0-3ec836b8435c
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 29, 2018
Package DI Number
10842472106869
Quantity per Package
24
Contains DI Package
00842472106862
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 | 202 |
2 | A medical device with a moderate to high risk that requires special controls. | 86 |