DEVICE: RAN-16(2.8), F/G (00858690006891)

Device Identifier (DI) Information

RAN-16(2.8), F/G
16GA x 2.8"
In Commercial Distribution
RAN-16(2.8)N5T
RANFAC CORP.
00858690006891
GS1

1
121622872 *Terms of Use
RAN-16(2.8)N5T, F/G PN 74048-03M
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KNW Instrument, Biopsy
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131157 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 2.8 Inch
Needle Gauge: 16 Gauge
CLOSE

Device Record Status

edf14122-25c5-407a-89bb-54f7ecd4649f
February 03, 2022
4
May 04, 2017
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20858690006895 8 10858690006898 In Commercial Distribution Case
10858690006898 10 00858690006891 In Commercial Distribution Inner Pack
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
5085884400
info@ranfac.com
CLOSE