Duns Number:009831413
Device Description: Quala gut chromic 4/0 27 C-6 suture absorbable
Catalog Number
P00635
Brand Name
Quala Chromic Gut Suture
Version/Model Number
P00635
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
GAL
Product Code Name
Suture, Absorbable, Natural
Public Device Record Key
0f15839a-3602-4779-9ba4-7af70c85fa06
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
D023P006351
Quantity per Package
12
Contains DI Package
D023P006350
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 | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |