Duns Number:109903521
Device Description: OUTFLOW TUBE SET HYSTER. (BOX OF 5)
Catalog Number
7209823
Brand Name
Hysteroscopic Outflow Tube Set
Version/Model Number
7209823
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K031616,K031616
Product Code
HIG
Product Code Name
INSUFFLATOR, HYSTEROSCOPIC
Public Device Record Key
f73e8b73-632d-4993-aaec-81cfe658294f
Public Version Date
January 31, 2020
Public Version Number
6
DI Record Publish Date
August 30, 2015
Package DI Number
23596010529514
Quantity per Package
5
Contains DI Package
03596010529510
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| 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 |