| Primary Device ID | D785ENGPP0 |
| NIH Device Record Key | b8715300-a57f-4542-9b92-49d071a101cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Paralleling Pin |
| Version Model Number | ENGAGE Paralleling Pin |
| Catalog Number | ENG-PP |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D785ENGPP0 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
[D785ENGPP0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2024-03-12 |
| D785ISIP50 | 5mm Paralleling Pin 5mm Diameter |
| D785ISIP40 | 4mm Paralleling Pin 4mm Diameter |
| D785ISIP3250 | 3.25mm Paralleling Pin 3.25mm Diameter |
| D785ENGPP0 | ENGAGE Paralleling Pin |