DEVICE: Bone Filler Device (06938695525017)

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Device Identifier (DI) Information

Bone Filler Device
FG2501
FG2501
Shanghai Kinetic Medical Co., Ltd.
06938695525017
GS1
1
KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit (including Bone Filler Device, Dilator, Cannula, Drill and Guide Wire) Puncture Needle KMC Medical Balloon Catheter Syringe Pump
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Bone grafting cannula A sterile rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of high-grade stainless steel with a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HRX Arthroscope
NDN Cement, Bone, Vertebroplasty
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Sterilization

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

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Storage and Handling
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 18 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 05, 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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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+862150720558
qingmeiwei@kineticmedinc.com
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