| Primary Device ID | 00810021436715 |
| NIH Device Record Key | 344300c6-b2eb-4343-adac-d033dfb7449a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DCI |
| Version Model Number | 5740 |
| Company DUNS | 032221423 |
| Company Name | DCI International, LLC |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 5035372445 |
| regulatory@dcionline.com | |
| Phone | 5035372445 |
| regulatory@dcionline.com | |
| Phone | 5035372445 |
| regulatory@dcionline.com | |
| Phone | 5035372445 |
| regulatory@dcionline.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021436715 [Primary] |
| EHZ | Evacuator, Oral Cavity |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810021436715]
Moist Heat or Steam Sterilization
[00810021436715]
Moist Heat or Steam Sterilization
[00810021436715]
Moist Heat or Steam Sterilization
[00810021436715]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-19 |
| Device Publish Date | 2024-12-11 |
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| 10810021435074 | Mouth Props, Large Adult |
| 10810021435067 | Mouth Props, Edentulous |
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