Duns Number:809784593
Device Description: SUR-FIT Natura® Stomahesive® Flexible Pre-Cut 4" X 4" Wafer Tan 1 1/8 Stoma, Flange Size 1 SUR-FIT Natura® Stomahesive® Flexible Pre-Cut 4" X 4" Wafer Tan 1 1/8 Stoma, Flange Size 1 3/4
Catalog Number
-
Brand Name
SUR-FIT NATURA
Version/Model Number
125272
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
EXE
Product Code Name
Protector, Ostomy
Public Device Record Key
b50fb2a4-0c72-4430-aad6-85d87acd32c1
Public Version Date
October 07, 2022
Public Version Number
2
DI Record Publish Date
March 22, 2019
Package DI Number
10768455101853
Quantity per Package
10
Contains DI Package
00768455101856
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 |