DEVICE: Occlutech® Steerable Guiding Sheath (07350048971156)

Device Identifier (DI) Information

Occlutech® Steerable Guiding Sheath
51GS014
In Commercial Distribution
51GS014
Oscor Inc.
07350048971156
GS1

1
101835833 *Terms of Use
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 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K120459 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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 Record Status

64ad6282-f4d9-4026-9246-b4a8f6c481ea
July 06, 2018
3
November 28, 2017
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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

[?]
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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