Primary Device ID | 08800011268459 |
NIH Device Record Key | 51335bb2-cc50-4088-88df-c74af9ac6b06 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bone Profile Drill |
Version Model Number | OTBP5500 |
Company DUNS | 695333960 |
Company Name | POINTIMPLANT Co., Ltd. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | MR Conditional |
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 | 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 | 08800011268459 [Primary] |
DZA | Drill, Dental, Intraoral |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
[08800011268459]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-28 |
Device Publish Date | 2025-05-20 |
08800011268480 | OTBP7000 |
08800011268473 | OTBP6500 |
08800011268466 | OTBP6000 |
08800011268459 | OTBP5500 |
08800011268442 | OTBP5000 |
08800011268435 | OTBP4500 |