DEVICE: LeGoo® LG250 (20358468019046)
Device Identifier (DI) Information
LeGoo® LG250
LG250
Not in Commercial Distribution
GENZYME CORPORATION
LG250
Not in Commercial Distribution
GENZYME CORPORATION
Occluder, Internal Vessel, Temporary
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
47043 | Intravascular occluding solution kit |
A collection of sterile devices intended as an alternative to vascular clamping to interrupt local blood flow through transient intraluminal obstruction during surgery, suturing of blood vessels, or interventional vascular procedures. It includes a liquid polymer (e.g., poloxamer) that is injected into a vein/artery, and devices to contain/administer the solution (e.g., pouch, syringe, injection cannula or catheter). The solution typically has reverse thermal characteristics (i.e., liquid at room temperature and gelled at body temperature) enabling the formation of an in vivo plug that occludes the vessel; it eventually dissolves or is purposely dissolved. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OBC | Occluder, internal vessel, temporary |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: one 2.5 mL syringe with 1 cannula (3.0 x 80 mm) |
Total Volume: 2.5 Milliliter |
Device Record Status
7a1f576e-a95c-40ea-905c-a0e6e2ea88d8
March 29, 2018
2
September 24, 2014
March 29, 2018
2
September 24, 2014
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 |
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
[?]
+1(508)661-1471
brian.nelson@genzyme.com +1(508)271-3304
paul.dawidczykjr@genzyme.com
brian.nelson@genzyme.com +1(508)271-3304
paul.dawidczykjr@genzyme.com