DEVICE: Bausch + Lomb (10757770058911)
Device Identifier (DI) Information
Bausch + Lomb
BL5628
In Commercial Distribution
BL5628
Bausch & Lomb Incorporated
BL5628
In Commercial Distribution
BL5628
Bausch & Lomb Incorporated
25 Ga. 7500 cpm vitrectomy handpiece
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 45074 | Vitrectomy system |
An assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric, pneumatic) through a dedicated hand-held instrument, which converts the energy into an oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This system will typically consist of a generator to provide the energy, an infusion and suction system to supply replacement fluid and remove debris, a cutting handpiece and cables, and a foot control. This assembly is typically used to treat diabetic vitreous haemorrhage, retinal detachment, epiretinal membrane, and macular hole.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| HQC | Unit, Phacofragmentation |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
6b71e1f1-bdb8-48d3-90c2-faf4ca7ddd57
May 15, 2024
3
August 02, 2018
May 15, 2024
3
August 02, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
00757770058914
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined