Duns Number:327681359
Device Description: MALLET ACCORDING TO COTTLE Ø30 MM WITH FLAT AND CONVEX END WEIGHT 350G, TOTAL LENGTH 180MM MALLET ACCORDING TO COTTLE Ø30 MM WITH FLAT AND CONVEX END WEIGHT 350G, TOTAL LENGTH 180MM / 7"
Catalog Number
70.301.05
Brand Name
LAZIC
Version/Model Number
70.301.05
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"
-
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
GFJ
Product Code Name
Mallet, Surgical, General & Plastic Surgery
Public Device Record Key
ac1f1f8e-fd71-477f-9b61-31bf7edc61cc
Public Version Date
December 30, 2020
Public Version Number
1
DI Record Publish Date
December 22, 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 | 1084 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1125 |