DEVICE: 25GA Sheilded Wide Angle Light Pipe - Universal (00632307001406)
Device Identifier (DI) Information
25GA Sheilded Wide Angle Light Pipe - Universal
PD125.14S
In Commercial Distribution
Peregrine Surgical, Llc
PD125.14S
In Commercial Distribution
Peregrine Surgical, Llc
25GA Sheilded Wide Angle Light Pipe - Universal
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? |
---|---|---|---|---|
45193 | Ophthalmic fibreoptic light instrument, single-use |
A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MPA | Endoilluminator |
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 |
---|
Needle Gauge: 25 Gauge |
Device Size Text, specify: 25 Gauge Needle |
Device Record Status
fc3197a5-70d5-429e-af67-2471f8b9f852
September 11, 2024
4
May 06, 2016
September 11, 2024
4
May 06, 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 |
---|---|---|---|---|---|
10632307001403 | 5 | 00632307001406 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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