Duns Number:315018218
Device Description: NOIR SUPREME Micro Ring Forceps, without weight, straight, 7 1/4", (185 mm), diam. 1 mm, r NOIR SUPREME Micro Ring Forceps, without weight, straight, 7 1/4", (185 mm), diam. 1 mm, ring tip, Golfball design handle, diamond dust coated, non-sterile, reusable
Catalog Number
FM627B
Brand Name
NOIR SUPREME
Version/Model Number
FM627B
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
-
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
HTD
Product Code Name
FORCEPS
Public Device Record Key
41f38dac-7950-4d20-a8d8-474a7dac16b4
Public Version Date
May 04, 2020
Public Version Number
1
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 |