Duns Number:058614483
Device Description: Suture Ligature with Delivery System,V-20
Catalog Number
ELW-42
Brand Name
Surgiwip
Version/Model Number
ELW-42
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 02, 2019
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
K912973,K912973
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
df055f4d-3cca-477e-9552-ce9eab1e918d
Public Version Date
December 06, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20884521132082
Quantity per Package
6
Contains DI Package
10884521132085
Package Discontinue Date
August 02, 2019
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 |