DEVICE: RadiaLux™ (00643169890145)
Device Identifier (DI) Information
RadiaLux™
50-101-1
In Commercial Distribution
MEDTRONIC NAVIGATION, INC.
50-101-1
In Commercial Distribution
MEDTRONIC NAVIGATION, INC.
RETRACTOR 50-101-1 RADIALUX US
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? |
---|---|---|---|---|
47991 | Self-retaining surgical retractor, single-use |
A sterile, hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAD | RETRACTOR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify: 800hPA-1060hPA |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
af56470e-45a7-4f2a-811b-cee61588c9ae
April 07, 2025
3
May 21, 2017
April 07, 2025
3
May 21, 2017
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com