Duns Number:792528510
Device Description: Sopher Ovum Forceps w/ratchet OL 280.0mm 1 1/2" 14mm
Catalog Number
-
Brand Name
Millennium
Version/Model Number
85-300P29344
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
037a76b3-ed51-4c77-a1a1-b6c5b26808f3
Public Version Date
December 04, 2019
Public Version Number
1
DI Record Publish Date
November 26, 2019
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 |