Duns Number:058614483
Device Description: Monofilament Absorbable Suture
Catalog Number
-
Brand Name
Caprosyn
Version/Model Number
CC-100-M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 05, 2016
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
K032586,K032586,K032586
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
29f2a519-209c-431c-a747-6910ed6fa870
Public Version Date
July 08, 2022
Public Version Number
4
DI Record Publish Date
October 22, 2015
Package DI Number
20884523005490
Quantity per Package
12
Contains DI Package
10884523005493
Package Discontinue Date
September 02, 2015
Package Status
Not in Commercial Distribution
Package Type
BX
| 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 |