Primary Device ID | 15056030400541 |
NIH Device Record Key | f87b2f9e-94d7-4e5e-8b2a-1aabd8be16ae |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Formed Irrigating Cystotomes |
Version Model Number | M3001-02/10 |
Catalog Number | M3001 |
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 | 15056030400541 [Unit of Use] |
GS1 | 25056030400548 [Primary] |
MED | Sterilant, Medical Devices |
Steralize Prior To Use | true |
Device Is Sterile | true |
[15056030400541]
Ethylene Oxide
[15056030400541]
Ethylene Oxide
[15056030400541]
Ethylene Oxide
[15056030400541]
Ethylene Oxide
[15056030400541]
Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-17 |
Device Publish Date | 2024-12-09 |
25056030400999 - Refractive Cannulae | 2025-04-02 25g x 7/8" Lin Lasik |
25056030401019 - Vitreoretinal Cannulae | 2025-04-02 25g Silicone Brush |
25056030401484 - Vitreoretinal Handpieces | 2025-04-02 Backflush/25g Soft Tip |
35056030400996 - Vitreoretinal Cannulae | 2025-04-02 23g x 4mm VFI |
35056030401009 - Vitreoretinal Cannulae | 2025-04-02 23g x 1 1/4" Asp Cann |
55056030400969 - Hydrodissection Cannulae | 2025-02-25 30g x 7/8" Hydrodissector |
15056030401746 - Bimanual I/A Systems | 2025-02-07 21g TW x 16m Bimanual |
35056030400781 - Hydrodissection Cannulae | 2024-12-17 25g Tapered Hydro |