| Primary Device ID | 35056030401672 |
| NIH Device Record Key | f3b17be5-bb7d-4d42-a6db-01f6fa255b9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bimanual Cannulae and Hand Pieces |
| Version Model Number | M5515-02/5 |
| Catalog Number | M5515 |
| Company DUNS | 504799313 |
| Company Name | STERIMEDIX LIMITED |
| Device Count | 5 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 15056030401678 [Primary] |
| GS1 | 35056030401672 [Unit of Use] |
| MED | Sterilant, Medical Devices |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[35056030401672]
Ethylene Oxide
[35056030401672]
Ethylene Oxide
[35056030401672]
Ethylene Oxide
[35056030401672]
Ethylene Oxide
[35056030401672]
Ethylene Oxide
[35056030401672]
Ethylene Oxide
[35056030401672]
Ethylene Oxide
[35056030401672]
Ethylene Oxide
[35056030401672]
Ethylene Oxide
[35056030401672]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-15 |
| Device Publish Date | 2024-10-07 |
| 25056030401668 | 21g x 5/8" Bimanual Irr |
| 15056030401715 | 21g x 5/8" Bimanual Irr |
| 35056030401689 | 23g x 5/8" Bimanual Asp |
| 45056030401655 | 23g x 5/8" Bimanual Irr |
| 15056030401616 | 21g x 5/8" Bimanual Irr |
| 15056030401586 | 21g x 5/8 Bimanual Irr |
| 35056030401672 | 21g x 7/8" Bimanual Asp |