Duns Number:315018218
Device Description: RANDALL Endometrial Biopsy Curette, curved, 9 1/2", (240 mm), luer lock, non-sterile, reus RANDALL Endometrial Biopsy Curette, curved, 9 1/2", (240 mm), luer lock, non-sterile, reusable
Catalog Number
ER012R
Brand Name
AESCULAP
Version/Model Number
ER012R
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCY
Product Code Name
CURETTE, UTERINE
Public Device Record Key
f3e6aaf8-2ea5-4290-943a-30623fdaa0c5
Public Version Date
July 20, 2021
Public Version Number
2
DI Record Publish Date
April 21, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |