Duns Number:071595540
Device Description: REFLEX ELC Endoscopic Clip Applier W/Titanium Clips, 10mm
Catalog Number
530
Brand Name
REFLEX
Version/Model Number
530
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
K924929,K924929,K924929
Product Code
HBT
Product Code Name
APPLIER, HEMOSTATIC CLIP
Public Device Record Key
d6613d77-3e4d-44e2-85f6-a2c7d308bb96
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20653405074813
Quantity per Package
6
Contains DI Package
30653405074810
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |