Duns Number:082594540
Device Description: KLEINERT-KUTZ TENDON RETRIEV FLEX 200MM
Catalog Number
MG091R
Brand Name
AESCULAP
Version/Model Number
MG091R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 27, 2021
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
GEN
Product Code Name
FORCEPS, GENERAL & PLASTIC SURGERY
Public Device Record Key
8f1bcf8e-1949-4815-8c3a-e8ca58779c1a
Public Version Date
June 02, 2021
Public Version Number
2
DI Record Publish Date
May 08, 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 |