Duns Number:792528510
Device Description: Teale Vulsellum Forceps Curved, 3x4 teeth OL 235mm(9 1/4")
Catalog Number
-
Brand Name
Millennium
Version/Model Number
85-300P22071
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
2c735557-bab2-404b-912c-cf6401a2130e
Public Version Date
December 01, 2020
Public Version Number
1
DI Record Publish Date
November 23, 2020
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 |