DEVICE: PINNACLE (00389701007571)
Device Identifier (DI) Information
PINNACLE
RSB702
In Commercial Distribution
RSB702
TERUMO MEDICAL CORPORATION
RSB702
In Commercial Distribution
RSB702
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 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: Do not store at extreme temperature and humidity |
Special Storage Condition, Specify: Avoid direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 10 Centimeter |
Catheter Gauge: 7 French |
Device Size Text, specify: Guidewire Compatibility: 0.038 Inch |
Device Record Status
63fb66d6-986a-46f7-8d7e-4e5996e57b0c
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 |
---|---|---|---|---|---|
30389701007572 | 10 | 00389701007571 | In Commercial Distribution | Shelfbox | |
50389701007576 | 10 | 30389701007572 | 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