DEVICE: LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) (10850007764330)
Device Identifier (DI) Information
LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)
B-20301-10
In Commercial Distribution
B-20301-10
Reshape Lifesciences Inc.
B-20301-10
In Commercial Distribution
B-20301-10
Reshape Lifesciences Inc.
LAP-BAND® Access Port Needle 3.5 inch Pouch
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? |
---|---|---|---|---|
17180 | Subcutaneous infusion/injection port needle |
A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LTI | Implant, Intragastric For Morbid Obesity |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P000008 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Do not use if package is damaged and consult instructions for use |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9247d222-c00f-4a41-8d61-68e1d694eea9
January 19, 2024
5
April 01, 2021
January 19, 2024
5
April 01, 2021
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:
00850007764333
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
844-937-7374
CustomerService@ReShapelifesci.com
CustomerService@ReShapelifesci.com