Duns Number:315304071
Device Description: SHEATH FOR HYSTEROSCOPE 21FR WL 205mm, round, distal end beveled, compatible with telesco SHEATH FOR HYSTEROSCOPE 21FR WL 205mm, round, distal end beveled, compatible with telescopes Ø 4mm, 30°, with Luer connection, bayonet-cap, reusable
Catalog Number
8988.03
Brand Name
NA
Version/Model Number
898803
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
FED
Product Code Name
endoscopic access overtube, gastroenterology-urology
Public Device Record Key
99b4271e-9db2-4890-8561-8d2fb8caf656
Public Version Date
March 11, 2019
Public Version Number
4
DI Record Publish Date
September 28, 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 |