DEVICE: GARRETT VASCULAR DILATOR (B09927000100)

Device Identifier (DI) Information

GARRETT VASCULAR DILATOR
2700-010
Not in Commercial Distribution

SONTEC INSTRUMENTS, INC.
B09927000100
HIBCC
September 21, 2018
1
040729840 *Terms of Use
GARRETT VASCULAR DILATOR
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
11268 Vascular dilator, reusable
A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DWP Dilator, Vessel, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K100518 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 8.25 Inch
Device Size Text, specify: 5mm Tip
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Device Record Status

56b7463b-94ac-4faf-8b17-bbfd3ab82fb8
September 21, 2018
7
August 19, 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

[?]
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
No
No
No CLOSE

Customer Contact

[?]
303-790-9411
info@sontecinstruments.com
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