Duns Number:809784593
Device Description: SUR-FIT Natura® Disposable Convex Inserts, 1 1/2" Inner Diameter, Flange Size 2 1/4"
Catalog Number
-
Brand Name
SUR-FIT NATURA
Version/Model Number
404012
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZS
Product Code Name
Appliance, Colostomy, Disposable
Public Device Record Key
ff3b01f2-0fd5-4ee5-b09b-22788438e295
Public Version Date
October 18, 2022
Public Version Number
3
DI Record Publish Date
March 22, 2019
Package DI Number
10768455107169
Quantity per Package
12
Contains DI Package
00768455107162
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |