Duns Number:316151174
Device Description: GOLD-CUT HERCULES® SURG WIRE CUTTER 18CM MAX 2,2 MM STEEL WIRE RIGHT HAND
Catalog Number
-
Brand Name
HERCULES® Wire Cutter
Version/Model Number
OL 603-18-01
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
HXZ
Product Code Name
Cutter, Wire
Public Device Record Key
c3a94cac-718f-4dc8-bb48-5f37572811dc
Public Version Date
November 25, 2020
Public Version Number
1
DI Record Publish Date
November 17, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |