DEVICE: Manan Medical Products, Inc. (00859013006130)
Device Identifier (DI) Information
Manan Medical Products, Inc.
502507
Not in Commercial Distribution
502507
MANAN MEDICAL PRODUCTS, INC.
502507
Not in Commercial Distribution
502507
MANAN MEDICAL PRODUCTS, INC.
Two Part Seldinger Access Needle
18GA.ETW X 2.875"
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 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. A stylet/obturator may be included with the needle, however additional introduction devices are not included (i.e., not a set). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWS | Instruments, Surgical, Cardiovascular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 2.875 Inch |
Device Record Status
e1b2a15d-d48e-44e7-8c8f-6adb2e6e8f16
June 06, 2024
4
October 26, 2016
June 06, 2024
4
October 26, 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 |
---|---|---|---|---|---|
20859013006134 | 3 | 10859013006137 | 2019-03-02 | Not in Commercial Distribution | Unit Boxes |
10859013006137 | 30 | 00859013006130 | 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
[?]
224-625-8331
David.Gasparik@argonmedical.com
David.Gasparik@argonmedical.com