DEVICE: PINNACLE (00389701007397)
Device Identifier (DI) Information
PINNACLE
RSS505
In Commercial Distribution
RSS505
TERUMO MEDICAL CORPORATION
RSS505
In Commercial Distribution
RSS505
TERUMO MEDICAL CORPORATION
PINNACLE Introducer Sheath
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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. |
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 |
---|
Catheter Gauge: 5 French |
Length: 25 Centimeter |
Device Size Text, specify: Guidewire Compatibility: 0.038 Inch |
Device Size Text, specify: Contents: Sheath and Dilator |
Device Record Status
845cb73e-9deb-4cf7-88a5-804f33c907c7
March 29, 2018
2
September 24, 2016
March 29, 2018
2
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 |
---|---|---|---|---|---|
30389701007398 | 10 | 00389701007397 | In Commercial Distribution | Shelfbox | |
50389701007392 | 10 | 30389701007398 | In Commercial Distribution | Carton |
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