| Primary Device ID | 35056030401740 |
| NIH Device Record Key | 7d758409-8b6e-4d5a-93b2-6457ba896758 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bimanual I/A Systems |
| Version Model Number | 5531NS-02/Y |
| Catalog Number | M5531 |
| Company DUNS | 504799313 |
| Company Name | STERIMEDIX LIMITED |
| 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 | 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 | 35056030401740 [Primary] |
| MED | Sterilant, Medical Devices |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
[35056030401740]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-18 |
| Device Publish Date | 2024-11-08 |
| 35056030401740 | 21g TW x 16m Bimanual |
| 15056030401746 | 21g TW x 16m Bimanual |