DEVICE: TourGuide™ Steerable Sheath (07350048971156)

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Device Identifier (DI) Information

TourGuide™ Steerable Sheath
51GS014
51GS014
Oscor Inc.
07350048971156
GS1
1
Steerable Guiding Sheath, 14F
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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 guide-catheter, single-use A sterile flexible tube intended to be used for the percutaneous transluminal passage and placement of guidewires and/or diagnostic/interventional devices (e.g., pacing leads, balloon dilatation catheter, stent and delivery system, or embolization device) within the vascular system. The guide catheter may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, multi-purpose, hockey stick, renal double curve); it typically has radiopaque markers so that it can be fluoroscopically tracked. It may include disposable introduction devices (e.g., needle, guidewire, dilator). This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DYB INTRODUCER, CATHETER
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Outer Diameter 16.8F (5.60 mm)
Device Size Text, specify: Sheath Usable Length 71 cm
Lumen/Inner Diameter: 4.5 Millimeter
Device Size Text, specify: Dilator Usable Length 89 cm
Device Size Text, specify: Sheath Overall Length 86 cm
Device Size Text, specify: Dilator Overall Length 93 cm
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Device Status

In Commercial Distribution
August 26, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
+1(727)937-2511
sales@oscor.com
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