DEVICE: 25GA Illuminating Laser Probe, SMA905 (00632307002120)
Device Identifier (DI) Information
25GA Illuminating Laser Probe, SMA905
GA-0042270
In Commercial Distribution
Peregrine Surgical, Llc
GA-0042270
In Commercial Distribution
Peregrine Surgical, Llc
25GA Illuminating Laser Probe, SMA905
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 |
---|---|
HQF | Laser, ophthalmic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K031023 | 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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Needle Gauge: 25 Gauge |
Device Size Text, specify: 25 Gauge Needle |
Device Record Status
05cd6fcd-e92d-44e8-b4a1-4ecb1391d449
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 |
---|---|---|---|---|---|
10632307002127 | 10 | 00632307002120 | 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
jayne@peregrine-surgical.com +1(215)348-0456
ryan@peregrine-surgical.com
jayne@peregrine-surgical.com +1(215)348-0456
ryan@peregrine-surgical.com