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. |