DEVICE: StabiliT® (00884450296417)

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Device Record History
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Device Identifier (DI) Information
StabiliT®
00884450296417
In Commercial Distribution
DF-4011L/A
Merit Medical Systems, Inc.
00884450296417
GS1

1
184763290 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
58032 Vertebral body cement cannula
A sterile, manual, tubular device designed to create a percutaneous access channel into a vertebral body prior to and during injection of orthopaedic cement into the vertebral body during kyphoplasty. It is typically inserted under fluoroscopic guidance to treat a patient diagnosed with vertebral compression fractures (VCFs) in the lumbar or thoracic region of the spine. The device is typically made of stainless steel with an attached plastic handle and available in a kit of several equal size cannulae (e.g., 3 or 6) to provide access to one or more sites of intervention. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MDM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Gauge-10/11G
Device Size Text, specify: Size-Long
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Device Record Status
e706a4c8-f9e6-4109-94c7-248e51f0d0b0
April 09, 2018
1
March 09, 2018
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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
10884450296414 22 00884450296417 In Commercial Distribution
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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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