Duns Number:040729840
Device Description: STERNAL WIRE TWISTER NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED BROAD 5 X 20 MILLIMETERS JAW STERNAL WIRE TWISTER NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED BROAD 5 X 20 MILLIMETERS JAW 7.75 INCHES QUANTUM
Catalog Number
1103-153Q
Brand Name
STERNAL WIRE TWISTER NEEDLE HOLDER
Version/Model Number
1103-153Q
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
HXK
Product Code Name
HOLDER, NEEDLE; ORTHOPEDIC
Public Device Record Key
c5fddb31-4a1b-45cd-8958-ccf4a6870fea
Public Version Date
February 24, 2021
Public Version Number
7
DI Record Publish Date
September 12, 2018
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |