Primary Device ID | 08800011265441 |
NIH Device Record Key | 748ff951-3f4e-4c21-b7d5-7bbc294d1e51 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fixture Analog |
Version Model Number | OSTLA300 |
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 | true |
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 | 08800011265441 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
[08800011265441]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-03 |
Device Publish Date | 2025-02-21 |
08800011264772 | OSTLA400 |
08800011264765 | OSTLA350 |
08800011265441 | OSTLA300 |
08800011268701 | PIFA4812 |