Duns Number:078352849
Device Description: Needle holder is a surgical instrument, similar to a hemostat, used to hold a suturing nee Needle holder is a surgical instrument, similar to a hemostat, used to hold a suturing needle for closing wounds during suturing and surgical procedures. These Needle holders have tungsten carbide tips which give better grip and wear out slower than stainless steel.
Catalog Number
Needle Holder - T/C
Brand Name
Needle Holder - T/C
Version/Model Number
Needle Holder - T/C
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
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
bdfbceb6-367b-4998-925c-aac3b28af596
Public Version Date
February 11, 2021
Public Version Number
1
DI Record Publish Date
February 03, 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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |