DEVICE: VISTA BRITE TIP (20705032042113)

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Device Record History
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Device Identifier (DI) Information
VISTA BRITE TIP
SM7341
In Commercial Distribution
SM7341
CORDIS CORPORATION
20705032042113
GS1

1
806136177 *Terms of Use
GC 6F .067 100CM JR5 ST
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
17846 Vascular guide-catheter, single-use
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K021593 000
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Do not use if package is damanged
Special Storage Condition, Specify: Store in cool, dark, dry place
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
74407555-8759-4fb8-ad61-478e22a03d86
October 14, 2024
10
August 01, 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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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