DEVICE: NeoMagic (B339350250)

Device Identifier (DI) Information

NeoMagic
350-25
In Commercial Distribution
350-25
NEO MEDICAL INC.
B339350250
HIBCC

1
015510540 *Terms of Use
1.9 / 2.0Fr Needle & Tearaway Sheath Introducer
CLOSE

Device Characteristics

MR Unsafe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Vascular catheter introduction set A collection of sterile, 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FOZ Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K983916 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep Away From Sunlight
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 1.9 French
Catheter Gauge: 2.0 French
CLOSE

Device Record Status

64b0dd34-a3ea-4dd0-aee2-0b681abda2b9
July 06, 2018
3
September 24, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B339350255 10 B339350250 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE