DEVICE: Introducer set with hemostatic valve (20889942000354)
Device Identifier (DI) Information
Introducer set with hemostatic valve
DYNJINTROL8
Not in Commercial Distribution
DYNJINTROL8
Oscor Inc.
DYNJINTROL8
Not in Commercial Distribution
DYNJINTROL8
Oscor Inc.
Introducer set with hemostatic valve, 8F
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? |
---|---|---|---|---|
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYB | INTRODUCER, CATHETER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K090114 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Syringe 10 cc |
Device Size Text, specify: Guidewire Length: 50 cm, OD: 0.038 in |
Device Size Text, specify: Dilator Length 28 cm |
Lumen/Inner Diameter: 2.7 Millimeter |
Device Size Text, specify: Sheath Length 23 cm |
Device Size Text, specify: Needle 18 G |
Device Record Status
8ae75ccb-c3fb-4d06-8563-d18e35fefe8f
March 20, 2024
6
November 28, 2017
March 20, 2024
6
November 28, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10889942000357
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(727)937-2511
sales@oscor.com
sales@oscor.com