Primary Device ID | 08800041054114 |
NIH Device Record Key | 0f4d8f95-d1b1-4f12-8f8e-2e281932d56f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SD REAMER SET |
Version Model Number | SD-CA |
Company DUNS | 689846448 |
Company Name | Surgident Co.,Ltd. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 | 08800041054114 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
[08800041054114]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-19 |
Device Publish Date | 2023-10-11 |
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08800041065738 - Implant Removal Kit Gen II | 2023-11-02 |
08800041065745 - Screw Fixation Kit | 2023-11-02 |
08800041065752 - Drill Stop Kit | 2023-11-02 |
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08800041065776 - Contra Torque | 2023-11-02 |