Duns Number:839138955
Device Description: Hystro Sheath Double Seal Luer Cap is intended to be fitted to an endoscope biopsy port to
Catalog Number
HYST01
Brand Name
AED Hystero Sheath Double Seal Leur Cap
Version/Model Number
HYST01
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
K141515
Product Code
HIH
Product Code Name
Hysteroscope (And Accessories)
Public Device Record Key
fd66c535-dc29-417f-b25f-928d5ee797c2
Public Version Date
March 19, 2021
Public Version Number
2
DI Record Publish Date
November 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 | 579 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6418 |