Duns Number:315304071
Device Description: UTERUS GRASPING FORCEPS Ø 6.5MM WL 100MM by Saigres, double-toothed, TL 262mm, reusable
Catalog Number
8370.00
Brand Name
NA
Version/Model Number
837000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 02, 2020
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
HDC
Product Code Name
TENACULUM, UTERINE
Public Device Record Key
279a7e93-0c64-468d-88fe-ebd72c7edc04
Public Version Date
August 19, 2022
Public Version Number
6
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 |