DEVICE: PINNACLE (00389701007533)
Device Identifier (DI) Information
PINNACLE
RSB601
In Commercial Distribution
RSB601
TERUMO MEDICAL CORPORATION
RSB601
In Commercial Distribution
RSB601
TERUMO MEDICAL CORPORATION
PINNACLE R/O II Introducer Sheath with Radiopaque Marker
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYB | INTRODUCER, CATHETER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Avoid direct sunlight |
Special Storage Condition, Specify: Do not store at extreme temperature and humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Guidewire Compatibility: 0.038 Inch |
Length: 6 Centimeter |
Catheter Gauge: 6 French |
Device Record Status
bb6ec85d-2f85-4da8-9d06-89d1637f4df6
March 20, 2024
4
September 24, 2016
March 20, 2024
4
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 |
---|---|---|---|---|---|
50389701007538 | 10 | 30389701007534 | In Commercial Distribution | Carton | |
30389701007534 | 10 | 00389701007533 | In Commercial Distribution | Shelfbox |
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
[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
tmccustomer.admin@terumomedical.com