Duns Number:809784593
Device Description: Esteem®+ One-Piece Drainable Pre-Cut, Invisiclose® With Filter, Standard 12", Opaque 1 9/1 Esteem®+ One-Piece Drainable Pre-Cut, Invisiclose® With Filter, Standard 12", Opaque 1 9/16", 40Mm
Catalog Number
-
Brand Name
ESTEEM+
Version/Model Number
421862
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
EXH
Product Code Name
BAG, URINARY, ILEOSTOMY
Public Device Record Key
05f62dbb-9312-4fab-af88-7446d2b0d677
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
10768455155566
Quantity per Package
10
Contains DI Package
00768455155569
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 |