Duns Number:049290364
Device Description: 3.00MM DIA., HYDRO THERMAL ABLATION FIBEROPTIC ENDOSCOPE WITH SCOPE ADAPTER FOR HTA SHEET 3.00MM DIA., HYDRO THERMAL ABLATION FIBEROPTIC ENDOSCOPE WITH SCOPE ADAPTER FOR HTA SHEET - AUTOCLAVABLE
Catalog Number
52-4211
Brand Name
ELMED
Version/Model Number
52-4211
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
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
016a0486-f63b-4db1-ba67-7e78ad801ffe
Public Version Date
March 13, 2020
Public Version Number
1
DI Record Publish Date
March 05, 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4068 |