Duns Number:058614483
Device Description: Monofilament Nylon
Catalog Number
X-1229
Brand Name
Monosof
Version/Model Number
X-1229
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
K900531,K900531
Product Code
GAR
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
Public Device Record Key
34ed1d33-3a01-4987-82be-63d113fd9ef0
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
September 02, 2015
Package DI Number
20884521139722
Quantity per Package
12
Contains DI Package
10884521139725
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 |