DEVICE: RadiaLux™ (00643169890145)

Device Identifier (DI) Information

RadiaLux™
50-101-1
In Commercial Distribution

MEDTRONIC NAVIGATION, INC.
00643169890145
GS1

1
835233107 *Terms of Use
RETRACTOR 50-101-1 RADIALUX US
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GAD RETRACTOR
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

af56470e-45a7-4f2a-811b-cee61588c9ae
April 07, 2025
3
May 21, 2017
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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