Duns Number:002144145
Device Description: Pull-out Suture Set Surgical Steel w/ Monofilament 316L Stainless Steel 4-0 8" Loop
Catalog Number
D10191
Brand Name
ETHICON
Version/Model Number
D10191
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
K170767,K946173,K170767,K946173
Product Code
GAQ
Product Code Name
SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
Public Device Record Key
45c6ce1b-205f-4c6e-8fc5-ae4796b40670
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2016
Package DI Number
30705031238903
Quantity per Package
12
Contains DI Package
10705031238909
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |