MinerOss® X BH0024
GUDID 00614950007882
MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 2.0G/4.0CC
ACE SURGICAL SUPPLY CO., INC.
Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived| Primary Device ID | 00614950007882 |
| NIH Device Record Key | f96b4b7a-15ff-4e87-9643-f3bbc9ba5c0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MinerOss® X |
| Version Model Number | MINX-CAN2.0GR |
| Catalog Number | BH0024 |
| Company DUNS | 042763706 |
| Company Name | ACE SURGICAL SUPPLY CO., INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Weight | 2 Gram |
| Weight | 2 Gram |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00614950007882 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170541
FDA Product Code
| NPM | BONE GRAFTING MATERIAL, ANIMAL SOURCE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-06 |
On-Brand Devices [MinerOss® X]
| 00614950008896 | MinerOss X COLLAGEN SIZE 6X7X8MM |
| 00614950008889 | MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 0.25G/.5CC |
| 00614950007974 | MinerOss®X CORTICAL PARTICLE SIZE 500-1000µ 2.0G/3.2CC |
| 00614950007967 | MinerOss®X CORTICAL PARTICLE SIZE 500-1000µ 1.0G/1.6CC |
| 00614950007950 | MinerOss®X CANCELLOUS PARTICLE SIZE 250-1000µ 0.5G/1.0CC |
| 00614950007943 | MinerOss®X COLLAGEN SIZE 10X11X12MM |
| 00614950007936 | MinerOss® X COLLAGEN SIZE 8X9X9MM |
| 00614950007929 | MinerOss®X SYRINGE PARTICLE SIZE 250-1000µ 0.5CC |
| 00614950007912 | MinerOss®X SYRINGE PARTICLE SIZE 250-1000µ .25CC |
| 00614950007905 | MinerOss®X SYRINGE PARTICLE SIZE 250-1000µ 1.0CC |
| 00614950007899 | MinerOss X COLLAGEN SIZE 6X7X8MM |
| 00614950007882 | MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 2.0G/4.0CC |
| 00614950007875 | MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 1.0G/2.0CC |
| 00614950007868 | MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 0.25G/.5CC |
| 00614950007851 | MinerOss® X CORTICAL PARTICLE SIZE 500-1000µ 0.5G/.8CC |
Trademark Results [MinerOss]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MINEROSS 78694701 3218922 Live/Registered |
Evollution IP Holdings, Inc. 2005-08-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.