Duns Number:317931954
Device Description: Socket Attachment Block with poplar wood, block: Ø 148 mm, height: 65 mm, max. patient wei Socket Attachment Block with poplar wood, block: Ø 148 mm, height: 65 mm, max. patient weight 125 kg
Catalog Number
12A5
Brand Name
Socket Attachment Block block Ø 148 mm
Version/Model Number
12A5
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISY
Product Code Name
Joint, Knee, External Limb Component
Public Device Record Key
c9a6d736-07d0-4318-992a-7593c41222cb
Public Version Date
November 05, 2020
Public Version Number
2
DI Record Publish Date
October 15, 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 | 64 |