Duns Number:040729840
Device Description: Barraquer Needle Holder With Lock Round Handle Standard Straight Tip Titanium
Catalog Number
-
Brand Name
Barraquer Needle Holder
Version/Model Number
T15-3925
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"
Yes
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
HCF
Product Code Name
INSTRUMENT, LIGATURE PASSING AND KNOT TYING
Public Device Record Key
e2bd2e9a-7102-495a-a032-43a2bd320de6
Public Version Date
September 05, 2022
Public Version Number
1
DI Record Publish Date
August 26, 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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |