Duns Number:327681359
Device Description: HARDY FAHLBUSCH SICLE-DISSECTOR CURVED DOWNWARDS LEFT, SHARP TOTAL LENGTH 240 MM / 9 1/2", HARDY FAHLBUSCH SICLE-DISSECTOR CURVED DOWNWARDS LEFT, SHARP TOTAL LENGTH 240 MM / 9 1/2", BLACK
Catalog Number
70.132.14 B
Brand Name
LAZIC
Version/Model Number
70.132.14 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
4cfd3a7e-2813-445a-a3a9-789e8a37dc1a
Public Version Date
November 19, 2021
Public Version Number
1
DI Record Publish Date
November 11, 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 |