DEVICE: Launcher (10721902459150)

Device Identifier (DI) Information

Launcher
LA6MAC35
In Commercial Distribution

MEDTRONIC, INC.
10721902459150
GS1

1
006261481 *Terms of Use
CATHETER LA6MAC35 LA 6F 100CM MA35
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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
DQY CATHETER, PERCUTANEOUS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K021256 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: Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
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Clinically Relevant Size

[?]
Size Type Text
Length: 100.0 Centimeter
Catheter Gauge: 6.0 French
Device Size Text, specify: Curve MAC3.5
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Device Record Status

e3045422-d25d-45e8-be34-1cd3009f8704
July 06, 2018
3
May 27, 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

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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