Duns Number:044606982
Device Description: ILS Circular Sizer Set for use with Ethicon Endo-Surgery Intraluminal Staplers. Set contai ILS Circular Sizer Set for use with Ethicon Endo-Surgery Intraluminal Staplers. Set contains 1 each: 25mm, 29mm, &33mm Circular Sizer
Catalog Number
CSS
Brand Name
NA
Version/Model Number
CSS
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
-
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
-
Product Code
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
84404e8a-207d-4ed2-ba14-b25ca50dee70
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 15, 2016
Package DI Number
30705036003827
Quantity per Package
6
Contains DI Package
20705036003820
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |