Duns Number:327681359
Device Description: BONE SCOOP 45° ANGLED Ø 3 MM CURVED DOWN, WORKING LENGTH 125 MM / 5" TOTAL LENGTH 240 MM / BONE SCOOP 45° ANGLED Ø 3 MM CURVED DOWN, WORKING LENGTH 125 MM / 5" TOTAL LENGTH 240 MM / 9 1/2", BLACK
Catalog Number
70.143.21 B
Brand Name
LAZIC
Version/Model Number
70.143.21 B
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
GDI
Product Code Name
Dissector, Surgical, General & Plastic Surgery
Public Device Record Key
6cd3672a-47e0-47a8-9cbc-8ea88bba0b81
Public Version Date
June 18, 2021
Public Version Number
1
DI Record Publish Date
June 10, 2021
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 |