Duns Number:082594540
Device Description: WITTNER BPSY FRCP TH 4X8 STR 220WL 395MM
Catalog Number
MG194R
Brand Name
AESCULAP
Version/Model Number
MG194R
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
518f07e4-2440-4907-bacd-62787cbb7662
Public Version Date
September 02, 2020
Public Version Number
1
DI Record Publish Date
August 25, 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 | 3239 |
2 | A medical device with a moderate to high risk that requires special controls. | 683 |