| Primary Device ID | 15056030400503 |
| NIH Device Record Key | c72c2ea2-1ec5-4a91-8abc-edcc0f4a6a07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Formed Capsularhexis Cystotomes |
| Version Model Number | M3610S-02SP/10 |
| Catalog Number | M3000D |
| Company DUNS | 504799313 |
| Company Name | STERIMEDIX LIMITED |
| Device Count | 10 |
| 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 | 15056030400503 [Unit of Use] |
| GS1 | 25056030400500 [Primary] |
| MED | Sterilant, Medical Devices |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[15056030400503]
Ethylene Oxide
[15056030400503]
Ethylene Oxide
[15056030400503]
Ethylene Oxide
[15056030400503]
Ethylene Oxide
[15056030400503]
Ethylene Oxide
[15056030400503]
Ethylene Oxide
[15056030400503]
Ethylene Oxide
[15056030400503]
Ethylene Oxide
[15056030400503]
Ethylene Oxide
[15056030400503]
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 |
| 15056030400534 | 25g x 5/8" Cyst Fmd |
| 50560304005200 | 27g x 5/8" Cyst Fmd |
| 35056030400644 | 25g x 5/8" Cyst Short Cvd |
| 15056030400503 | 25g x 5/8" Cyst Fmd |
| 45056030400511 | 27g x 5/8" Cyst Fmd |
| 05056030400636 | 25g x 5/8" Cyst Ang |
| 05056030400599 | 27g x 7/8" Cyst Fmd |
| 05056030400537 | 25g x 5/8" Cyst Fmd |