| Primary Device ID | 00860002195056 |
| NIH Device Record Key | b6442a45-291d-4d4f-8b7f-225afbfd2a1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ebner 502 Handle 30 degree Down Head Angle |
| Version Model Number | 10325-02 |
| Company DUNS | 949461941 |
| Company Name | MAXILON LABORATORIES INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com | |
| Phone | (603)-594-9300 |
| maxilon@maxilon.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860002195056 [Primary] |
| GAC | Rasp, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
[00860002195056]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-08 |
| Device Publish Date | 2021-10-29 |
| 00860002195032 - ebner 502 Handle Straight Head | 2021-11-08 The ebner 502 expanded bone grafter is intended for bone removal and autogenous bone grafting. The instrument is comprised of |
| 00860002195049 - ebner 502 Handle 30 degree Up Head Angle | 2021-11-08 The ebner 502 expanded bone grafter is intended for bone removal and autogenous bone grafting. The instrument is comprised of |
| 00860002195056 - ebner 502 Handle 30 degree Down Head Angle | 2021-11-08The 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. |
| 00860002195056 - ebner 502 Handle 30 degree Down Head Angle | 2021-11-08 The ebner 502 expanded bone grafter is intended for bone removal and autogenous bone grafting. The instrument is comprised of |
| 20860002195005 - Mx-Grafter | 2020-08-11 The Mx-Grafter Bone Grafting System is a manual, self-contained, sterile, single use instrument for the removal, harvest, and gr |
| 00860002195001 - Mx-Grafter | 2020-03-10 The Mx-Grafter Bone Grafting System is a manual, self-contained, sterile, single use instrument for the removal, harvest, and gr |
| 00860002195025 - ebner 500 Series Blade | 2020-02-04 The ebner 502 expanded bone grafter is intended for bone removal and autogenous bone grafting. The instrument is comprised of |