Primary Device ID | D785ENGAGECOMPACTKIT0 |
NIH Device Record Key | 41cc5ede-1bf9-409b-9c8c-68b8c53e850d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SURGICAL KIT |
Version Model Number | ENGAGE SURGICAL INSTRUMENTATION COMPACT KIT |
Catalog Number | ENGAGE COMPACT KIT |
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 | true |
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 | D785ENGAGECOMPACTKIT0 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
Moist Heat or Steam Sterilization
[D785ENGAGECOMPACTKIT0]
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 |
D785GUIDEDSURGERYKIT0 | GUIDED SURGERY SURGICAL INSTRUMENTATION KIT |
D785ENGAGECOMPACTKIT0 | ENGAGE SURGICAL INSTRUMENTATION COMPACT KIT |