OCO Biomedical
GUDID 10817417020777
The AEU-1000-OCO Dental Implant Motor System is a drive system for instruments and tools used in dentistry for implant procedures.
ASEPTICO, INC.
Dental surgical power tool motorized handpiece/set, electric| Primary Device ID | 10817417020777 |
| NIH Device Record Key | a4b11de7-cb01-4bb7-9769-a630789ac1e7 |
| Commercial Distribution Discontinuation | 2032-07-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OCO Biomedical |
| Version Model Number | AEU-1000-OCO |
| Company DUNS | 016853348 |
| Company Name | ASEPTICO, 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 | false |
| Lot Batch | false |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10817417020777 [Primary] |
FDA Product Code
| EKX | Handpiece, Direct Drive, Ac-Powered |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10817417020777]
Moist Heat or Steam Sterilization
[10817417020777]
Moist Heat or Steam Sterilization
[10817417020777]
Moist Heat or Steam Sterilization
[10817417020777]
Moist Heat or Steam Sterilization
[10817417020777]
Moist Heat or Steam Sterilization
[10817417020777]
Moist Heat or Steam Sterilization
[10817417020777]
Moist Heat or Steam Sterilization
[10817417020777]
Moist Heat or Steam Sterilization
[10817417020777]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-22 |
| Device Publish Date | 2022-07-14 |
On-Brand Devices [OCO Biomedical]
| 10817417020777 | The AEU-1000-OCO Dental Implant Motor System is a drive system for instruments and tools used in |
| 10817417021125 | Implant / Endodontic Dental Systems |
| 10817417021118 | Implant / Endodontic Dental Systems |
Trademark Results [OCO Biomedical]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OCO BIOMEDICAL 86182623 4596947 Live/Registered |
OCO Biomedical, Inc. 2014-02-03 |
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