DEVICE: PINNACLE PRECISION ACCESS SYSTEM (00389701010786)

Device Identifier (DI) Information

PINNACLE PRECISION ACCESS SYSTEM
70-6160
In Commercial Distribution
70-6160
TERUMO MEDICAL CORPORATION
00389701010786
GS1

1
131489882 *Terms of Use
PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath
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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.
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FDA Product Code

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Product Code Product Code Name
DYB INTRODUCER, CATHETER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Avoid direct sunlight
Special Storage Condition, Specify: Do not store at extreme temperature and humidity
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Clinically Relevant Size

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Size Type Text
Length: 10 Centimeter
Catheter Gauge: 6 French
Device Size Text, specify: Contents: Sheath, Dilator, Guidewire (0.021 Inch Nitinol) and Needle (21 Gauge Taper Tip Echogenic)
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Device Record Status

df6b0a23-aa2d-4a34-b5a9-950e3068a5e2
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50389701010781 10 30389701010787 In Commercial Distribution Carton
30389701010787 10 00389701010786 In Commercial Distribution Shelfbox
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
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