Duns Number:687503532
Device Description: EQ-S (Pink) Full kit
Catalog Number
-
Brand Name
EQ-S
Version/Model Number
026-220
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
-
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
JET
Product Code Name
Pick, Massaging
Public Device Record Key
25e9b721-8fab-49bb-8254-2ba9b91220d6
Public Version Date
March 10, 2020
Public Version Number
1
DI Record Publish Date
March 02, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
U | Unclassified | 11 |