DEVICE: HINGE PEDIATRIC PLATING SYSTEM (07540194004321)

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Device Identifier (DI) Information

HINGE PEDIATRIC PLATING SYSTEM
HPS030-C-PKG2
HPS030-C-PKG2
Pega Medical Inc
07540194004321
GS1
2
Cannulated Screw 30mm Length
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Growth-correction orthopaedic fixation plate kit A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.
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FDA Product Code

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Product Code Product Code Name
HWC Screw, fixation, bone
HRS Plate, fixation, bone
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: keep at room temperature
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Clinically Relevant Size

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Size Type Text
Length: 30 Millimeter
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Device Status

In Commercial Distribution
December 07, 2016

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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: 07540194004475 CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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+1(450)688-5144 242
egarcia@pegamedical.com
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