Duns Number:315018218
Device Description: NOIR SUPREME Micro Needle Holder, straight, 7 1/4", (210 mm), spring type, Golfball design NOIR SUPREME Micro Needle Holder, straight, 7 1/4", (210 mm), spring type, Golfball design handle, with ratchet, diamond dust coated, suture up to 5/0, non-sterile, reusable
Catalog Number
FM652B
Brand Name
NOIR SUPREME
Version/Model Number
FM652B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 10, 2022
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
HXK
Product Code Name
HOLDER, NEEDLE; ORTHOPEDIC
Public Device Record Key
84200528-a4a4-4358-8c50-f4082f43dac1
Public Version Date
January 19, 2022
Public Version Number
3
DI Record Publish Date
April 24, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |