Duns Number:645680588
Device Description: Intended Use: Halsey needle holders are finger ring forceps that assist surgeons in guidin Intended Use: Halsey needle holders are finger ring forceps that assist surgeons in guiding and inserting suture needles.Packaging: Packaging shall be as per customer requirements e.g set of 26 or set of 50.
Catalog Number
SU-13-0176-13
Brand Name
Halsey Needle Holder
Version/Model Number
SU-13-0176-13
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
FHQ
Product Code Name
Holder, Needle, Gastroenterologic
Public Device Record Key
d815f948-2511-490d-8fbc-8eabae29b4ec
Public Version Date
September 19, 2022
Public Version Number
1
DI Record Publish Date
September 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 | 38 |