Duns Number:079720472
Device Description: Memory Hard Wire Basket
Catalog Number
MWB-2.5X5-D
Brand Name
Memory
Version/Model Number
G57267
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 29, 2021
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
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
K171969
Product Code
LQR
Product Code Name
DISLODGER, STONE, BILIARY
Public Device Record Key
90012f81-edf3-4461-aab3-7df7f02af1e8
Public Version Date
July 30, 2021
Public Version Number
4
DI Record Publish Date
April 26, 2019
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 | 669 |
2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
3 | A medical device with high risk that requires premarket approval | 370 |
U | Unclassified | 242 |