Duns Number:809784593
Device Description: Post Op Kit: Natura® Two-Piece, Drainable, 2 1/4" (57Mm), Transparent, Standard, With Invi Post Op Kit: Natura® Two-Piece, Drainable, 2 1/4" (57Mm), Transparent, Standard, With Invisiclose® Tail Closure, With Durahesive® Moldable Skin Bar
Catalog Number
-
Brand Name
NATURA
Version/Model Number
416921
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
FON
Product Code Name
BAG, DRAINAGE, WITH ADHESIVE, OSTOMY
Public Device Record Key
6087fa79-8b67-4988-8ee2-5f311cf297ea
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
10768455115928
Quantity per Package
6
Contains DI Package
00768455115921
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |