Duns Number:315304071
Device Description: SHEATH FOR HYSTEROSCOPE 12FR WL 246mm, oval, working channel 3Fr, distal end beveled, and SHEATH FOR HYSTEROSCOPE 12FR WL 246mm, oval, working channel 3Fr, distal end beveled, and telescopes Ø 2.7mm, 30°, with Luer connection, bayonet-cap, reusable
Catalog Number
8974.121
Brand Name
NA
Version/Model Number
8974121
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HIH
Product Code Name
HYSTEROSCOPE (AND ACCESSORIES)
Public Device Record Key
3ef286aa-c30d-4fd4-a65a-b6fb778514f2
Public Version Date
April 28, 2021
Public Version Number
8
DI Record Publish Date
September 27, 2016
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |