DEVICE: Advocate (05397132006020)

Device Identifier (DI) Information

Advocate
A18070100090
In Commercial Distribution

ARRAVASC LIMITED
05397132006020
GS1

1
896165250 *Terms of Use
Advocate 0.018" PTA Catheter (7.0mm x 100mm x 900mm)
CLOSE

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. 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?
17184 Peripheral angioplasty balloon catheter, basic
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LIT Catheter, Angioplasty, Peripheral, Transluminal
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151153 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a dark, dry, cool place. Avoid extended exposure to light, organic solvents, ionizing radiation or ultraviolet light
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 100 Millimeter
Outer Diameter: 7.0 Millimeter
CLOSE

Device Record Status

bce96bee-6510-4451-9d28-b1e51eef8218
August 09, 2019
4
September 01, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+353091758939
cs@arravasc.com
CLOSE