DEVICE: NeoMagic (B33920763000)
Device Identifier (DI) Information
NeoMagic
2076-300
In Commercial Distribution
2076-300
NEO MEDICAL INC.
2076-300
In Commercial Distribution
2076-300
NEO MEDICAL INC.
1.9/2.0 Fr, 27ga, Sharps Safety Needle & Tearaway Sheath Introducer
Device Characteristics
MR Unsafe | |
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? |
---|---|---|---|---|
58865 | Vascular catheter introduction set, nonimplantable |
A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYB | Introducer, Catheter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K022099 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep Dry |
Special Storage Condition, Specify: Keep Away from Sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Needle Gauge: 27 Gauge |
Catheter Gauge: 1.9 French |
Catheter Gauge: 2.0 French |
Device Record Status
3f1b6e63-8ef7-467e-85b0-83ce9479fd7a
March 20, 2024
5
September 24, 2016
March 20, 2024
5
September 24, 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 |
---|---|---|---|---|---|
B33920763005 | 10 | B33920763000 | 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
[?]
888-450-3334
support@neomedicalinc.com
support@neomedicalinc.com