Duns Number:058614483
Device Description: Monofilament Absorbable Suture
Catalog Number
XX-2113
Brand Name
Maxon
Version/Model Number
XX-2113
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 22, 2020
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
K990951,K990951
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
5a485ee0-ae38-4787-aa00-955530a43a1d
Public Version Date
February 01, 2022
Public Version Number
4
DI Record Publish Date
September 02, 2015
Package DI Number
20884523004868
Quantity per Package
12
Contains DI Package
10884523004861
Package Discontinue Date
May 22, 2020
Package Status
Not 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 |