Duns Number:058614483
Device Description: Monofilament Polybutester, DX-13, 1x Clear Strand
Catalog Number
-
Brand Name
Novafil
Version/Model Number
XX2214
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 12, 2021
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
K990952,K990952
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
77634895-de74-4403-8d1a-0fb2226292a7
Public Version Date
February 16, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20884521584638
Quantity per Package
12
Contains DI Package
10884521584631
Package Discontinue Date
February 12, 2021
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |