Primary Device ID | D785ISIC500 |
NIH Device Record Key | b332d3c9-5b27-4cda-9a5a-522c7d5354f5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CB TRIP |
Version Model Number | 5.0mm CB TRIP ISI &TSI |
Catalog Number | ISIC 5.0 |
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 | 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 | D785ISIC500 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
Moist Heat or Steam Sterilization
[D785ISIC500]
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 |
D785ISIC2933250 | 2.9,3.0 & 3.25mm CROWN AND BRIDGE IMPRESSION PICKUP |
D785ISIC500 | 5.0mm CROWN AND BRIDGE TRIP (ISI &TSI) |
D785ISIC400 | 4.0mm CRWON AND BRIDGE TRIP (ISI &TSI) |