DEVICE: TourGuide™ Steerable Sheath (07350048971149)

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Device Identifier (DI) Information

TourGuide™ Steerable Sheath
51GS012
51GS012
Oscor Inc.
07350048971149
GS1
1
Steerable Guiding Sheath, 12F
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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, single-lumen tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It 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, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. 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

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Size Type Text
Lumen/Inner Diameter: 4.2 Millimeter
Device Size Text, specify: Outer Diameter 15.9F (5.30 mm)
Device Size Text, specify: Dilator Overall Length 93 cm
Device Size Text, specify: Sheath Overall Length 86 cm
Device Size Text, specify: Dilator Usable Length 89 cm
Device Size Text, specify: Sheath Usable Length 71 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

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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
Yes
No CLOSE

Customer Contact

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