DEVICE: Merit Advance® (10884450846664)
Device Identifier (DI) Information
Merit Advance®
B
In Commercial Distribution
SL18T71W
Merit Medical Systems, Inc.
B
In Commercial Distribution
SL18T71W
Merit Medical Systems, Inc.
No description.
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? |
---|---|---|---|---|
33961 | General surgical procedure kit, non-medicated, single-use |
A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
|
Active | false |
58977 | Basic intravenous administration set, noninvasive |
A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYB | Introducer, catheter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Accepts Guide Wire-0.038" (0.97 mm) |
Device Size Text, specify: Gauge-18G |
Device Size Text, specify: Length (cm)-7.0 cm |
Device Record Status
0aa583ad-b1c3-46ad-a289-6fdbf85f470d
January 27, 2025
1
January 18, 2025
January 27, 2025
1
January 18, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20884450846661 | 4 | 10884450846664 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00884450846667
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined