Duns Number:109903521
Device Description: SVCE REPL CU HYSTER FLUID MGMT SYSTEM
Catalog Number
7210164S
Brand Name
Hysteroscopic Fluid Management
Version/Model Number
7210164S
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K031616
Product Code
HIG
Product Code Name
INSUFFLATOR, HYSTEROSCOPIC
Public Device Record Key
f4bc36b0-e2ac-4866-a0e1-763b2ee0eb24
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
June 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |