Primary Device ID | 08800271225438 |
NIH Device Record Key | f718a187-9ee3-45a0-a711-f7cc19f198dd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SIMPLE KIT |
Version Model Number | HSMPK |
Company DUNS | 689051793 |
Company Name | Osstem Implant Co., Ltd. |
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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800271225438 [Primary] |
NYE | Fixture Mount Kit |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
[08800271225438]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-09-18 |
Device Publish Date | 2024-09-10 |
08800271225438 - SIMPLE KIT | 2024-09-18 |
08800271225438 - SIMPLE KIT | 2024-09-18 |
08800271218164 - Taper Drill | 2024-08-28 |
08800271218171 - Taper Drill | 2024-08-28 |
08800271218188 - Taper Drill | 2024-08-28 |
08800271218195 - Taper Drill | 2024-08-28 |
08800271218201 - Taper Drill | 2024-08-28 |
08800271218218 - Taper Drill | 2024-08-28 |
08800271218225 - Taper Drill | 2024-08-28 |