DEVICE: 25GA Curved Illuminating Laser Probe (00632307002175)
Device Identifier (DI) Information
25GA Curved Illuminating Laser Probe
7625.ALCU
In Commercial Distribution
Peregrine Surgical, Llc
7625.ALCU
In Commercial Distribution
Peregrine Surgical, Llc
25GA Curved Illuminating Laser Probe
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
61162 | Ophthalmic laser system beam guide |
A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HQB | PHOTOCOAGULATOR AND ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K132614 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 25 Gauge Needle |
Needle Gauge: 25 Gauge |
Device Record Status
69f8b3c8-31a3-4183-9650-1af9d9cd0954
September 11, 2024
4
September 01, 2016
September 11, 2024
4
September 01, 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 |
---|---|---|---|---|---|
10632307002172 | 6 | 00632307002175 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(215)348-0456
ryan@peregrine-surgical.com +1(215)348-0456
jayne@peregrine-surgical.com
ryan@peregrine-surgical.com +1(215)348-0456
jayne@peregrine-surgical.com