Duns Number:071595540
Device Description: ABC D-FLEX FLEXIBLE LAPAROSCOPIC PROBE FOR CONMED SYSTEM 7550 AND HELIXAR
Catalog Number
60-8627-001
Brand Name
ABC D-FLEX
Version/Model Number
60-8627-001
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
K151229,K151229,K151229
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
ca9c8267-16cc-440e-9b40-c068af7660e3
Public Version Date
October 25, 2021
Public Version Number
1
DI Record Publish Date
October 15, 2021
Package DI Number
20653405082504
Quantity per Package
1
Contains DI Package
10653405082507
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 |