Duns Number:025460908
Device Description: CANNULA,ENDO BIOPSY,EASY FLEX, 25/BX
Catalog Number
MDS6303010
Brand Name
Medline
Version/Model Number
MDS6303010
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
K092982,K092982
Product Code
HHK
Product Code Name
CURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)
Public Device Record Key
712c41ba-fe45-42d5-a675-a25df5d16689
Public Version Date
February 09, 2021
Public Version Number
1
DI Record Publish Date
February 01, 2021
Package DI Number
20888277632148
Quantity per Package
25
Contains DI Package
10888277632141
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |