Primary Device ID | D78562060 |
NIH Device Record Key | f8636a92-ffd2-4937-892c-1c7065786e3b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sinus Lift Surgical Kit |
Version Model Number | Sinus Lift Surgical Case |
Catalog Number | 6206 |
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 | D78562060 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D78562060]
Moist Heat or Steam Sterilization
[D78562060]
Moist Heat or Steam Sterilization
[D78562060]
Moist Heat or Steam Sterilization
[D78562060]
Moist Heat or Steam Sterilization
[D78562060]
Moist Heat or Steam Sterilization
[D78562060]
Moist Heat or Steam Sterilization
[D78562060]
Moist Heat or Steam Sterilization
[D78562060]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-04 |
Device Publish Date | 2024-06-26 |
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 |
D78562010 - Small Diameter Surgical Kit | 2024-07-04 Small Diameter Surgical Kit Caddy |
D78562020 - Osteotome Tray | 2024-07-04 Osteotome Tray |
D78562050 - Engage Compact Kit | 2024-07-04 Engage Compact Kit Case |