DEVICE: NA (04546540754172)

Device Identifier (DI) Information

NA
233-061-100
Not in Commercial Distribution
233-061-100
STRYKER CORPORATION
04546540754172
GS1
October 21, 2016
1
187502109 *Terms of Use
LEG HOLDER PAD SET
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Leg intraoperative positioner A preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during intraoperative procedures, typically orthopaedic surgery (e.g., fracture reduction, arthroscopy, arthroplasty). It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating table are typically included. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
NBH ACCESSORIES,ARTHROSCOPIC
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FDA Premarket Submission

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

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6938d16c-ae00-46c0-9bc5-4693d3825302
March 29, 2018
2
August 31, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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
No
No
No CLOSE

Customer Contact

[?]
+1(866)624-4422
xx@xx.xx
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