Duns Number:809784593
Device Description: Esteem Synergy Professional Kit, Non-Sterile (Extra Large)Kit Contains, 5 each 14 in Trans Esteem Synergy Professional Kit, Non-Sterile (Extra Large)Kit Contains, 5 each 14 in Transparent, Straight Drainable Pouches, Extra Large
Catalog Number
-
Brand Name
ESTEEM SYNERGY
Version/Model Number
409275
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 2022
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)
Yes
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
b91c5cf5-3aba-4065-a12c-757fc154c8d5
Public Version Date
May 23, 2022
Public Version Number
3
DI Record Publish Date
November 09, 2018
Package DI Number
10768455105264
Quantity per Package
4
Contains DI Package
00768455105267
Package Discontinue Date
May 20, 2022
Package Status
Not 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 |