DEVICE: Elation 5™ (00884450383476)
Device Identifier (DI) Information
Elation 5™
00884450383476
In Commercial Distribution
EX6
Merit Medical Systems, Inc.
00884450383476
In Commercial Distribution
EX6
Merit Medical Systems, Inc.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
45712 | Gastrointestinal/biliary dilation balloon catheter, non-medicated |
A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNQ | Dilator, esophageal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm |
Device Size Text, specify: Balloon Length-8 cm |
Device Size Text, specify: Catheter Length-180 cm |
Device Size Text, specify: Catheter Length-180 cm; Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm; Balloon Length-8 cm; Catheter Length-180 cm |
Device Size Text, specify: Balloon Length-8 cm; Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm; Balloon Length-8 cm; Catheter Length-180 cm |
Device Record Status
ee74462a-4fb7-45da-9963-1da53fa30ef3
April 25, 2025
3
April 29, 2019
April 25, 2025
3
April 29, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10884450383473 | 20 | 00884450383476 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined