DEVICE: CER-SUB-825-M (00850023741189)

Device Identifier (DI) Information

CER-SUB-825-M
8GA X 25CM
In Commercial Distribution
CER-SUB-825-M
RANFAC CORP.
00850023741189
GS1

1
121622872 *Terms of Use
Cervos 8GA Delivery Cannula P/N: 74379-01M Customer#: 12153
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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
FGY Cannula, Injection
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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
Needle Gauge: 8 Gauge
Length: 25 Centimeter
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Device Record Status

2646f5c4-a809-4ae2-a353-d5ffb474abf4
May 17, 2021
1
May 08, 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
10850023741186 1 00850023741189 In Commercial Distribution Inner Pack
20850023741183 24 10850023741186 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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