DEVICE: HipFix® Baseplate (00841439107058)

Device Identifier (DI) Information

HipFix® Baseplate
MTPLVC04
Not in Commercial Distribution
MTPLVC04
MEDTEC, INC.
00841439107058
GS1
October 11, 2021
1
103977526 *Terms of Use
(79 x 60 x 1cm)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
40901 Radiological pelvis positioner
A device intended to facilitate adequate positioning and immobilization of the patient's pelvic area during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LNH System, nuclear magnetic resonance imaging
IYE Accelerator, linear, medical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K093738 000
K950866 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

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

798300f6-f433-4857-af05-4a2319e11eac
October 11, 2021
8
August 02, 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
Yes
No CLOSE

Customer Contact

[?]
+1(712)737-8688
radiotherapy.complaints@civcort.com
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