Primary Device ID | D78562000 |
NIH Device Record Key | d41f2c10-a7d1-4a3c-b648-b12303fc5bc1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Complete Surgical Kit |
Version Model Number | Complete Surgical Kit Caddy |
Catalog Number | 6200 |
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 | D78562000 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
Moist Heat or Steam Sterilization
[D78562000]
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 |
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 | 2024-07-04Complete Surgical Kit Caddy |
D78562000 - Complete Surgical Kit | 2024-07-04 Complete Surgical Kit Caddy |