DEVICE: RAN-811-OT (00857878007101)

Device Identifier (DI) Information

RAN-811-OT
8 Gauge x 11cm
In Commercial Distribution
RAN-811-OT
RANFAC CORP.
00857878007101
GS1

1
121622872 *Terms of Use
RAN-811-OT Sterile, Ranfac Drillable Stylet P/N: 74274-01M
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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
Length: 11 Centimeter
Needle Gauge: 8 Gauge
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Device Record Status

f9cabaa5-18b8-48da-b5ac-dbc539b66a5e
September 24, 2021
1
September 16, 2021
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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
10857878007108 1 00857878007101 In Commercial Distribution Box
20857878007105 24 10857878007108 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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