Duns Number:109903521
Device Description: SPINE NEEDLE,17 GAUGE CRAWFORD, 6 INCH STRAIGHT
Catalog Number
KNS-1706-10
Brand Name
Perc
Version/Model Number
KNS-1706-10
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
28898519-bf9b-4a88-8157-37a1e8e24440
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
August 29, 2015
Package DI Number
20817470003448
Quantity per Package
10
Contains DI Package
00817470003444
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |