Primary Device ID | 25056030401484 |
NIH Device Record Key | 0e57c84f-8975-4675-96a9-bc9b06f6d397 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Vitreoretinal Handpieces |
Version Model Number | M4503-02/5 |
Catalog Number | M4503 |
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 | 15056030401487 [Primary] |
GS1 | 25056030401484 [Unit of Use] |
MED | Sterilant, Medical Devices |
Steralize Prior To Use | true |
Device Is Sterile | true |
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
[25056030401484]
Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-02 |
Device Publish Date | 2025-03-25 |
25056030400999 - Refractive Cannulae | 2025-04-02 25g x 7/8" Lin Lasik |
25056030401019 - Vitreoretinal Cannulae | 2025-04-02 25g Silicone Brush |
25056030401484 - Vitreoretinal Handpieces | 2025-04-02Backflush/25g Soft Tip |
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 |