Duns Number:949461941
Device Description: The ebner 502 expanded bone grafter is intended for bone removal and autogenous bone graft The ebner 502 expanded bone grafter is intended for bone removal and autogenous bone grafting. The instrument is comprised of a stainless steel handle and blade (blade labeled for single use). The blade shaves bone from cortical surfaces producing short convoluted ribbons. While being cut, shavings combine with blood and flow into the handle's head. This graft material, an osseous coagulum, is then delivered with the handle directly to the recipient site, or to a bowl.Blades are standardized so that ebner 500 BLADEs can be used with any ebner 500 HANDLE (501, 502... 5nn). Before the clinician's first case, he should become familiar with the instrument including the mounting and removal of the blade.
Catalog Number
-
Brand Name
ebner 502 Handle 30 degree Down Head Angle
Version/Model Number
10325-02
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMI
Product Code Name
File, Bone, Surgical
Public Device Record Key
b6442a45-291d-4d4f-8b7f-225afbfd2a1c
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 29, 2021
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 | 6 |