Duns Number:079375431
Device Description: Gastrointestinal Anchor Set, SAF-T-PEXY* T-Fasteners
Catalog Number
91521
Brand Name
AVANOS
Version/Model Number
91521
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
Yes
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
KGC
Product Code Name
TUBE, GASTRO-ENTEROSTOMY
Public Device Record Key
0003a5bf-865f-4cf1-87d9-bf4d86e3ef40
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
May 23, 2020
Package DI Number
10350770915217
Quantity per Package
25
Contains DI Package
00350770915210
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |