| Primary Device ID | D7858514BOS0 |
| NIH Device Record Key | 88f43c38-5cd5-480a-a202-5e3f37b14712 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TSI/ERI/Macro Locator Abutment |
| Version Model Number | Locator inserts-4 Pack |
| Catalog Number | 8514 |
| Company DUNS | 094146123 |
| Company Name | OCO BIOMEDICAL INC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7858514BOS0 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
[D7858514BOS0]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-04-08 |
| D785895560 | Locator Abutment 4mm 4mm Diameter 6mm Height |
| D785895450 | Locator Abutment 4mm 4mm Diameter 5mm height |
| D785895340 | Locator Abutment 4mm 4mm Diameter 4mm Height |
| D785895230 | Locator Abutment 4mm 4mm Diameter 3mm Height |
| D785895120 | Locator Abutment 4mm 4mm Diameter 2mm Height |
| D785895070 | Locator Abutment 4mm 4mm Diameter .7mm Height |
| D7858915ORANGE0 | Locator Inserts-4 Pack Extended Range Replacement Male, 2lbs. (Orange) |
| D7858548RED0 | Locator Inserts-4 Pack Extended Range Replacement Male, 3lbs. (Red) |
| D7858547GREEN0 | Locator Inserts-4 Pack Extended Range Replacement Male, 4lbs. (Green) |
| D7858529BLUE0 | Locator Inserts-4 Pack Replacement Male, 1.5lbs. (Blue) |
| D7858527PINK0 | Locator Inserts-4 Pack Replacement Male, Light Retention, 3lbs. (Pink) |
| D7858524CLEAR0 | Locator Inserts-4 Pack Replacement Male, 5lbs. (Clear) |
| D7858514BOS0 | Locator inserts-4 Pack Block Out Spacers |
| D785190260 | Locator Abutment 5/6mm 5/6mm Diameter 6mm Height |
| D785190150 | Locator Abutment 5/6mm 5/6mm Diameter 5mm Height |
| D785190040 | Locator Abutment 5/6mm 5/6mm Diameter 4mm Height |
| D785189930 | Locator Abutment 5/6mm 5/6mm Diameter 3mm Height |
| D785189820 | Locator Abutment 5/6mm 5/6mm Diameter 2mm Height |
| D785189760 | Locator Abutment 3.25mm 3.25mm Diameter 6mm Height |
| D785189650 | Locator Abutment 3.25mm 3.25mm Diameter 5mm Height |
| D785189540 | Locator Abutment 3.25mm 3.25mm Diameter 4mm Height |
| D785189430 | Locator Abutment 3.25mm 3.25mm Diameter 3mm Height |
| D785189320 | Locator Abutment 3.25mm 3.25mm Diameter 2mm Height |
| D785189270 | Locator Abutment 3.25mm 3.25mm Diameter .7mm Height |