Duns Number:792528510
Device Description: Schroeder (Braun) Tenaculum, single tooth, Sklar Blue Radial Frequency coated for electros Schroeder (Braun) Tenaculum, single tooth, Sklar Blue Radial Frequency coated for electrosurgery
Catalog Number
-
Brand Name
Avalign
Version/Model Number
GL851
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
-
Product Code
HCZ
Product Code Name
FORCEPS, SURGICAL, GYNECOLOGICAL
Public Device Record Key
4acbc6ca-32f4-4287-9ea9-06b4e6c1f25f
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
March 23, 2017
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 | 6832 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9482 |