| Primary Device ID | D78550UCLAE0 |
| NIH Device Record Key | a943e56d-464b-4668-b550-297455bad7f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bone Level UCLA |
| Version Model Number | 5mm UCLA |
| Catalog Number | 5045 UCLA E (TiB) |
| 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 | D78550UCLAE0 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
Moist Heat or Steam Sterilization
[D78550UCLAE0]
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 | 2016-04-13 |
| D78560UCLANE0 | 6mm UCLA 6mm Diameter Non-Engaging Delrin Ti Base |
| D78560UCLAE0 | 6mm UCLA 6mm Diameter Engaging Delrin Ti Base |
| D7856057UCLANEDEL0 | 6mm UCLA NE (DEL) 6mm Diameter Non-Engaging Delrin Base |
| D7856057UCLANE0 | 7mm UCLA 7mm Diameter Non-Engaging Delrin Ti Base |
| D7856057UCLAEDEL0 | 6mm UCLA E (DEL) 6mm Diameter Engaging Delrin Base |
| D7856057UCLAE0 | 7mm UCLA 7mm Diameter Engaging Delrin Ti Base |
| D78560578UCLANEDEL0 | 8mm UCLA NE (DEL) 8mm Diameter Non-Engaging Delrin Base |
| D78560578UCLANE0 | 8mm UCLA 8mm Diameter Non-Engaging Delrin Ti Base |
| D78560578UCLAEDEL0 | 8mm UCLA E (DEL) 8mm Diameter Engaging Delrin Base |
| D78560578UCLAE0 | 8mm UCLA 8mm Diameter Engaging Delrin Ti Base |
| D78560577UCLANEDEL0 | 7mm UCLA NE (DEL) 7mm Diameter Non-Engaging Delrin Base |
| D78560577UCLAEDEL0 | 7mm UCLA E (DEL) 7mm Diameter Engaging Delrin Base |
| D78550UCLANE0 | 5mm UCLA 5mm Diameter Non-Engaging Delrin Ti Base |
| D78550UCLAE0 | 5mm UCLA 5mm Diameter Engaging Delrin Ti Base |
| D7855045UCLANEDEL0 | 5mm UCLA NE (DEL) 5mm Diameter Non-Engaging Delrin Base |
| D7855045UCLAEDEL0 | 5mm UCLA E (DEL) 5mm Diameter Engaging Delrin Base |
| D78540UCLANE0 | 4mm UCLA 4mm Diameter Non-Engaging Delrin Ti Base |
| D78540UCLAE0 | 4mm UCLA 4mm Diameter Engaging Delrin Ti Base |
| D7854035UCLANEDEL0 | 4mm UCLA NE (DEL) 4mm Diameter Non-Engaging Delrin Base |
| D7854035UCLAEDEL0 | 4mm UCLA E (DEL) 4mm Diameter Engaging Delrin Base |
| D785325UCLANE0 | 3.25mm UCLA 3.25mm Diameter Non-Engaging Delrin Ti Base |
| D785325UCLAE0 | 3.25 UCLA 3.25mm Diameter Engaging Delrin Ti Base |
| D78532530UCLANEDEL0 | 3.25mm UCLA NE (DEL) 3.25mm Diameter Non-Engaging Delrin Base |