Duns Number:044606982
Device Description: The Circular Sizer is a non-sterile, stainless steel device sized 31 mm to correspond with The Circular Sizer is a non-sterile, stainless steel device sized 31 mm to correspond with the head sizes of ETHICON Circular Staplers (Intraluminal Staplers).
Catalog Number
CS31
Brand Name
Circular Sizer
Version/Model Number
CS31
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
0fda8f51-cf0e-4a24-be45-9cc2a510b1b6
Public Version Date
July 24, 2019
Public Version Number
1
DI Record Publish Date
July 16, 2019
Package DI Number
30705036015431
Quantity per Package
16
Contains DI Package
20705036015434
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 |