DEVICE: GLIDESHEATH SLENDER (00389701011370)

Device Identifier (DI) Information

GLIDESHEATH SLENDER
50-1070
In Commercial Distribution
50-1070
TERUMO MEDICAL CORPORATION
00389701011370
GS1

1
131489882 *Terms of Use
GLIDESHEATH SLENDER Nitinol Hydrophilic Coated Introducer Sheath
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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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. Keep Dry.
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
Catheter Gauge: 7 French
Device Size Text, specify: Needle: 21 Gauge x 1.5 Inch Metal
Length: 10 Centimeter
Device Size Text, specify: Guidewire: 0.021 Inch x 45 Centimeter Nitinol
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Device Record Status

585e626c-1db8-409d-818c-c17e06c09d5c
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
30389701011371 5 00389701011370 In Commercial Distribution Shelfbox
50389701011375 10 30389701011371 In Commercial Distribution Carton
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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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