| Primary Device ID | 74546951527043 |
| NIH Device Record Key | a785c521-9d19-4658-85ee-97f530aa2b10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MANI SURGICAL BURS |
| Version Model Number | 28mm #2 |
| Company DUNS | 690622428 |
| Company Name | MANI, INC. |
| Device Count | 4 |
| DM Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546951527044 [Primary] |
| GS1 | 74546951527043 [Unit of Use] |
| EJL | BUR, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
[74546951527043]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-17 |
| Device Publish Date | 2022-10-08 |
| 74546951527081 | MANI CARBIDE BURS |
| 74546951527074 | MANI CARBIDE BURS |
| 74546951527067 | MANI CARBIDE BURS |
| 74546951527050 | MANI CARBIDE BURS |
| 74546951527043 | MANI CARBIDE BURS |
| 74546951527036 | MANI CARBIDE BURS |
| 74546951525636 | MANI CARBIDE BURS |
| 74546951525629 | MANI CARBIDE BURS |
| 74546951617010 | MANI CARBIDE BURS |
| 74546951617003 | MANI CARBIDE BURS |
| 74546951616990 | MANI CARBIDE BURS |