Duns Number:315304071
Device Description: HOOK SCISSORS Ø 3.4MM particularly suitable for lateral cutting and smoothing, jaw sectio HOOK SCISSORS Ø 3.4MM particularly suitable for lateral cutting and smoothing, jaw section angled 45° to the right, sheath straight, WL 130mm, reusable
Catalog Number
8404.62
Brand Name
NA
Version/Model Number
840462
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HRR
Product Code Name
SCISSORS, ORTHOPEDIC, SURGICAL
Public Device Record Key
12e0cf67-c106-44af-b9c9-fb0e3f83bc3a
Public Version Date
August 17, 2022
Public Version Number
1
DI Record Publish Date
August 09, 2022
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |