DEVICE: Midwest Medical Inc. (Private Label) (00859013006048)
Device Identifier (DI) Information
Midwest Medical Inc. (Private Label)
CNM2206-MM
In Commercial Distribution
CNM2206-MM
MANAN MEDICAL PRODUCTS, INC.
CNM2206-MM
In Commercial Distribution
CNM2206-MM
MANAN MEDICAL PRODUCTS, INC.
22 GA x 15CM MARKED CHIBA NEEDLE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
47540 | Soft-tissue biopsy needle, single-use |
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNW | Instrument, Biopsy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K851838 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 15 Centimeter |
Device Record Status
f7563c5c-9487-467a-9ee7-adc5bb663861
July 06, 2018
3
September 21, 2016
July 06, 2018
3
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20859013006042 | 10 | 10859013006045 | In Commercial Distribution | Shipper Box | |
10859013006045 | 10 | 00859013006048 | In Commercial Distribution | Unit Boxes |
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
[?]
224-625-8331
David.Gasparik@argonmedical.com
David.Gasparik@argonmedical.com