Duns Number:315304071
Device Description: UTERUS PROBE SZ MEDIUM Ø 7.5MM WL 56MM curved upwards, compatible with uterus manipulator
Catalog Number
8370.512
Brand Name
NA
Version/Model Number
8370512
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
HEW
Product Code Name
Culdoscope (and accessories)
Public Device Record Key
3ad0f169-6088-46b2-8220-f22523f636da
Public Version Date
March 18, 2019
Public Version Number
5
DI Record Publish Date
September 26, 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 |