DEVICE: RAN-11B (00850023741592)

Device Identifier (DI) Information

RAN-11B
11GA X 11CM
In Commercial Distribution
RAN-11B
RANFAC CORP.
00850023741592
GS1

1
121622872 *Terms of Use
RAN-11B PN: 74406-01M
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
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?
60478 Bone access cannula
A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KNW Instrument, Biopsy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131157 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Length: 11 Centimeter
Needle Gauge: 11 Gauge
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Device Record Status

47a67151-9a7f-4de7-95ec-6994adc14562
January 17, 2022
1
January 07, 2022
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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
10850023741599 10 00850023741592 In Commercial Distribution Inner Pack
20850023741596 12 10850023741599 In Commercial Distribution Case
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Secondary DI

[?]
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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
5085884400
info@ranfac.com
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