DEVICE: Bausch + Lomb (20757770482621)
Device Identifier (DI) Information
Bausch + Lomb
CX6805
In Commercial Distribution
CX6805
Bausch & Lomb Incorporated
CX6805
In Commercial Distribution
CX6805
Bausch & Lomb Incorporated
25 GA PNEUMATIC HSV CUTTER
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 59258 | Vitrectomy system micro-cutting unit |
A sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. This is a single-use device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
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
82f69eaa-bf50-4fc5-9bca-44de75bb93db
May 15, 2024
4
September 24, 2016
May 15, 2024
4
September 24, 2016
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:
00757770482627
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined