DEVICE: Maxx Cell (00857878007453)
Device Identifier (DI) Information
Maxx Cell
11GA X 11CM
In Commercial Distribution
MXC-2
RANFAC CORP.
11GA X 11CM
In Commercial Distribution
MXC-2
RANFAC CORP.
MC-RAN-11CSTS MAXX CELL WITH PREPARATION ACCESSORIES
PN 74317-02M
Customer# 0018407
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
16833 | Bone marrow biopsy procedure kit |
A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNW | Instrument, Biopsy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150563 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 11 Centimeter |
Needle Gauge: 11 Gauge |
Device Record Status
26d5d1a5-bed1-431f-a868-4418c1664b0f
September 13, 2018
1
August 13, 2018
September 13, 2018
1
August 13, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10857878007450 | 1 | 00857878007453 | In Commercial Distribution | Inner | |
20857878007457 | 15 | 10857878007450 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
5085884400
info@ranfac.com
info@ranfac.com