| Primary Device ID | 03760304681646 |
| NIH Device Record Key | 8025d531-4ca0-490a-9abf-291ffbb1845b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MENIX / FIXIT / ecoFIX |
| Version Model Number | Non sterile needle (x5) |
| Catalog Number | ANS9005461 |
| 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 | 03760304681646 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
[03760304681646]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-04 |
| Device Publish Date | 2025-06-26 |
| 03760304681653 | Non sterile needle (x10) |
| 03760304681646 | Non sterile needle (x5) |
| 03760304681639 | Non sterile needle (x1) |