DEVICE: DESTINATION (00389701006994)
Device Identifier (DI) Information
DESTINATION
RSR17
In Commercial Distribution
RSR17
TERUMO MEDICAL CORPORATION
RSR17
In Commercial Distribution
RSR17
TERUMO MEDICAL CORPORATION
DESTINATION Renal Guiding 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. |
Vascular guide-catheter, single-use | A sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. 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 |
---|
Length: 45 Centimeter |
Device Size Text, specify: Type: Renal Double Curve (RDC) with Tuohy-Borst Valve (TBV) |
Catheter Gauge: 6 French |
Device Size Text, specify: Maximum Guidewire Outer Diameter: 0.038 Inch |
Device Record Status
84f6d93c-24c6-442c-ac31-25d18ab68c2b
January 23, 2019
5
September 24, 2016
January 23, 2019
5
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 |
---|---|---|---|---|---|
50389701006999 | 10 | 00389701006994 | 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