Duns Number:113344790
Device Description: SALVIN 4-0 CHROMIC GUT C6(FS-2) NEEDLE 18" (45CM)
Catalog Number
-
Brand Name
L-558B
Version/Model Number
L-558B
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
GAL
Product Code Name
Suture, Absorbable, Natural
Public Device Record Key
d66ce84c-d6ea-4658-bb2d-0295744266d2
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
October 30, 2015
Package DI Number
10841336100524
Quantity per Package
12
Contains DI Package
00841336100527
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |
| 3 | A medical device with high risk that requires premarket approval | 3 |