| Primary Device ID | 08800197900280 |
| NIH Device Record Key | d910f625-6051-487e-890b-5d471758602e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MK Drill Bit |
| Version Model Number | MKDB-DG-08 * 10set |
| Company DUNS | 695009476 |
| Company Name | MK Meditech 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800197900280 [Primary] |
| QRQ | Non-Irrigation Endosseous Dental Implant Drill Bits |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
[08800197900280]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-08-30 |
| Device Publish Date | 2023-01-10 |
| 08800197900167 | The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for |
| 08800197900150 | The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for |
| 08800197900143 | The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for |
| 08800197900280 | MKDB-DG-08 * 10EA |
| 08800197900327 | The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for |