| Primary Device ID | 03760154003360 |
| NIH Device Record Key | bd415ad0-d98f-4bab-b291-a5da0381f445 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIXIT & ecoFIX |
| Version Model Number | Cleaning and sterilization basket |
| Catalog Number | EPA9000101 |
| Company DUNS | 772462123 |
| Company Name | S.B.M |
| 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 | 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 | 03760154003360 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
[03760154003360]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-29 |
| Device Publish Date | 2023-12-21 |
| 03760154002882 | FIXIT mallet to be used with FIXIT suture anchors for rotator cuff repair. |
| 03760154009744 | Punch Tap to be used with diameter 5.5 mm and 6.5 mm FIXIT and ecoFIX suture anchors for rotator |
| 03760154009737 | Punch Tap to be used with diameter 4.5 mm FIXIT and ecoFIX suture anchors for rotator cuff repai |
| 03760154003360 | FIXIT® / ecoFIX® cleaning and sterilization basket. |