Duns Number:082594540
Device Description: , non-sterile, reusable
Catalog Number
MG256R
Brand Name
AESCULAP
Version/Model Number
MG256R
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
HDQ
Product Code Name
DILATOR, CERVICAL, FIXED SIZE
Public Device Record Key
39c9746e-bf2f-4cd9-a3cc-533f23cbd3fd
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 |