DEVICE: Medistar/Hatch (Private Label) (00859013006031)
Device Identifier (DI) Information
Medistar/Hatch (Private Label)
FNM-2205-UG
Not in Commercial Distribution
FNM-2205-UG
MANAN MEDICAL PRODUCTS, INC.
FNM-2205-UG
Not in Commercial Distribution
FNM-2205-UG
MANAN MEDICAL PRODUCTS, INC.
22GA RW X 5 CM (CALIBRATED FRANSEEN WITH ECHOGENIC TIP)
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? |
---|---|---|---|---|
61502 | Vascular catheter introduction needle |
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNW | Instrument, Biopsy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K851831 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 5 Centimeter |
Device Record Status
85e86619-ca76-4773-91bb-0539927f0161
July 19, 2021
4
October 14, 2016
July 19, 2021
4
October 14, 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 |
---|---|---|---|---|---|
20859013006035 | 10 | 10859013006038 | 2019-03-02 | Not in Commercial Distribution | Unit Boxes |
10859013006038 | 10 | 00859013006031 | 2019-03-02 | Not in Commercial Distribution | Tyvek Pouch |
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
[?]
No Customer Contact currently defined