DEVICE: Durasphere ® (00858015005608)

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Device Identifier (DI) Information

Durasphere ®
890-204
890-204
Carbon Medical Technologies, Inc.
00858015005608
GS1
1
Injection Needle, Spinal Tip
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Submucosal injection needle A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used in conjunction with a syringe to administer substances (e.g., fluids, gels) into the submucosal layer of tissue (connective tissue layer beneath the mucosa), typically of anatomical structures with lumens. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FBK Endoscopic Injection Needle, Gastroenterology-Urology
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Sterilization

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

[?]
Storage and Handling
Handling Environment Temperature: between 60 and 90 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Angle: 15 degree
Length: 1.5 Inch
Needle Gauge: 18 Gauge
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Device Status

In Commercial Distribution
October 12, 2016

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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
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8882070262
info@carbonmed.com
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