DEVICE: MR Stylet (17340007000482)

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Device Record History
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Device Identifier (DI) Information
MR Stylet
4013-06
In Commercial Distribution

Clinical Laserthermia Systems AB
17340007000482
GS1

1
774856749 *Terms of Use
No description.
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Device Characteristics
MR Safe
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?
31670 Catheter stylet
A metal wire or flexible rod, typically with a plastic knob at the proximal end, that is inserted into the lumen of a catheter or cannula to provide internal reinforcement to increase the stiffness enough to facilitate manipulation and introduction into the body for various procedures. It is available in various lengths, diameters, and degrees of rigidity. Some types can include small passive magnets that generate a magnetic field which is detectable by an external catheter stylet magnet detector. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
GAH Stylet, Surgical, General & Plastic Surgery
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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 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
3372b3fe-977e-4dde-950e-f67365850eeb
March 29, 2018
2
December 06, 2016
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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
57340007000480 10 17340007000482 In Commercial Distribution
37340007000486 5 17340007000482 In Commercial Distribution
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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)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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