Duns Number:801895244
Device Description: LOOP Electrosurgical Excision Procedure (Contains Lidocaine with Epinephrine)
Catalog Number
-
Brand Name
LEEP REDIKIT
Version/Model Number
6061
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
K910253,K910253
Product Code
HEE
Product Code Name
Set, Anesthesia, Paracervical
Public Device Record Key
af6b43a9-b3df-4b32-a9ac-15130061b3cc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 02, 2016
Package DI Number
20888937000034
Quantity per Package
5
Contains DI Package
00888937000030
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 |