DEVICE: RAN-11B, F/G (00858690006174)

Device Identifier (DI) Information

RAN-11B, F/G
11 Gauge x 110mm
In Commercial Distribution
RAN-11B
RANFAC CORP.
00858690006174
GS1

1
121622872 *Terms of Use
RAN-11B, F/G 11 Gauge x 110mm P/N 74230-01M
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 11 Gauge
Length: 110 Millimeter
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Device Record Status

d8e2f07d-0d08-4347-ae78-97108fa94d0b
July 06, 2018
3
May 08, 2017
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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
10858690006171 10 00858690006174 In Commercial Distribution Inner Pack
20858690006178 12 10858690006171 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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