| Primary Device ID | D78529SDIOBPK0 |
| NIH Device Record Key | b8083a26-bf66-4783-9654-deb7c8f943fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 2.9 SDI O-BALL PROSTHETIC KIT |
| Version Model Number | 2.9MM SDI O-BALL PROSTHETIC KIT |
| Catalog Number | 2.9 SDI-OB PK |
| Company DUNS | 094146123 |
| Company Name | OCO BIOMEDICAL 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D78529SDIOBPK0 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-29 |
| Device Publish Date | 2024-04-19 |
| D7856006ENGPLS0 - Two Stage Bone Level Implant | 2024-10-07 6mm diameter X 6mm length Bone Level Implant |
| D785293325CBTI0 - SDI Crown and Bridge Abutments (Ti) | 2024-07-08 2.9/3/3.25MM CONVERT OB TO CB ABUTMENT (TITANIUM) |
| D785SDI2225CBTI0 - SDI Crown and Bridge Abutments (Ti) | 2024-07-08 2.2/2.5MM SDI C&B ABUTMENT |
| D785002CAPWOBN0 - HOUSING CAP WITH O-RING | 2024-07-04 002 CAP WITH O-RING INSERTED (002BN900) |
| D785325SB0 - SCAN BODY | 2024-07-04 TSI/ERI 3.25MM SCAN BODY |
| D78540SB0 - SCAN BODY | 2024-07-04 TSI/ERI 4.0MM SCAN BODY |
| D78550SB0 - SCAN BODY | 2024-07-04 TSI/ERI 5.0MM SCAN BODY |
| D78562000 - Complete Surgical Kit | 2024-07-04 Complete Surgical Kit Caddy |