Duns Number:082594540
Device Description: BALFOUR Abdominal Retractor, blade, depth: 64 mm, width: 77 mm, aluminium, non-sterile, re BALFOUR Abdominal Retractor, blade, depth: 64 mm, width: 77 mm, aluminium, non-sterile, reusable
Catalog Number
MB830A
Brand Name
AESCULAP
Version/Model Number
MB830A
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
GAD
Product Code Name
RETRACTOR
Public Device Record Key
5b704073-be3c-495e-8ac9-4b5237737da1
Public Version Date
May 18, 2020
Public Version Number
1
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 |