Duns Number:025460908
Device Description: EXTENDED 5MM BALL 13CM
Catalog Number
ESE1564
Brand Name
MEDLINE
Version/Model Number
ESE1564
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
K931338,K931338
Product Code
HGI
Product Code Name
ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
b7e3e507-ff94-4261-9fe7-99bae5fbc4eb
Public Version Date
October 04, 2021
Public Version Number
2
DI Record Publish Date
May 18, 2020
Package DI Number
40080196916307
Quantity per Package
10
Contains DI Package
10080196916306
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |