Duns Number:137835299
Catalog Number
-
Brand Name
Wallace
Version/Model Number
WBB-35X-05
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
MQH
Product Code Name
MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES)
Public Device Record Key
59686c1c-9d90-4580-a6ca-8b49896e26c9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 05, 2016
Package DI Number
15019315087332
Quantity per Package
10
Contains DI Package
35019315087336
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 104 |
2 | A medical device with a moderate to high risk that requires special controls. | 36112 |