Duns Number:801895244
Device Description: 4mm OD Curette with Vacu-Lok Syringe
Catalog Number
-
Brand Name
Uterine Explora Curette - Model I
Version/Model Number
MX124
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"
Yes
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
K001545,K001545
Product Code
HHK
Product Code Name
Curette, Suction, Endometrial (And Accessories)
Public Device Record Key
026385e4-cea3-409a-bfa7-dec60467ae09
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 27, 2016
Package DI Number
20888937003516
Quantity per Package
25
Contains DI Package
00888937003512
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |