Duns Number:604056226
Device Description: Needle Counters, Sterile, 40 Count, Magnetic & Foam, Solid Lid, box/50
Catalog Number
-
Brand Name
Key Surgical Needle Counters
Version/Model Number
NC-40-111
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
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
GAB
Product Code Name
Needle, Suturing, Disposable
Public Device Record Key
d70047c9-a0c0-414e-81a8-fa2df46ef9f9
Public Version Date
September 08, 2021
Public Version Number
3
DI Record Publish Date
December 09, 2020
Package DI Number
20849771030588
Quantity per Package
50
Contains DI Package
00849771030584
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |