Duns Number:002111896
Device Description: SHRPCHEMO 5Q/5L USA YELLOW, ROUND
Catalog Number
32028563
Brand Name
Vermed
Version/Model Number
SHRPCHEMO 5Q/5L USA YELLOW, ROUND
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071517,K071517,K071517
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
d165779a-5fd6-4975-86ac-06bc47e37722
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 01, 2017
Package DI Number
70009336008789
Quantity per Package
8
Contains DI Package
50009336008785
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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |