Duns Number:058614483
Device Description: Monofilament Absorbable Suture,HOS-11,1x Violet Strand
Catalog Number
-
Brand Name
Biosyn
Version/Model Number
CM-528
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
K000037,K000037
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
1342b5ce-86b1-4d28-83d9-156f635ff6b9
Public Version Date
September 13, 2022
Public Version Number
8
DI Record Publish Date
September 01, 2015
Package DI Number
20884523006107
Quantity per Package
36
Contains DI Package
10884523006100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |