DEVICE: Merit MAK™ (00884450008775)

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Device Record History
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Device Identifier (DI) Information
Merit MAK™
A
In Commercial Distribution
MAK505-PED
Merit Medical Systems, Inc.
00884450008775
GS1

1
184763290 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38128 Vascular dilator, single-use
A sterile, 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 single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
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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

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

[?]
Size Type Text
Device Size Text, specify: Introducer French Size (F)-5F
Device Size Text, specify: Needle Gauge (G)-21G
Device Size Text, specify: Introducer Length (cm)-10 cm (4")
Device Size Text, specify: Guide Wire Diameter (OD)-0.018" (0.46 mm)
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Device Record Status
a52345d5-2556-4d33-b854-f5c7fc680a92
August 12, 2024
1
August 02, 2024
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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
10884450008772 10 00884450008775 In Commercial Distribution
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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

[?]
No Customer Contact currently defined
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