DEVICE: SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM (07540194003010)

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Device Identifier (DI) Information

SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
SLM-26-320
SLM-26-320
Pega Medical Inc
07540194003010
GS1
1
SLIM Rod Ø2.6mm x 320mm
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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
Arthrodesis nail, sterile A sterile rod made of metal or other material (e.g., carbon fibre) designed to be inserted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] to immobilize by holding the ends of a fractured or diseased bone together (i.e., in position) for the purpose of joint fusion or arthrodesis (an operation to permanently fix a joint in position). The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HBS INSTRUMENT, CLIP FORMING/CUTTING
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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: 320 Millimeter
Outer Diameter: 2.6 Millimeter
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Device Status

In Commercial Distribution
October 20, 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: No Unit of Use DI Numbers Found 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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