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.
10850007764330
GS1

10
022894714 *Terms of Use
10811955020411
LAP-BAND® Access Port Needle 3.5 inch Pouch
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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
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FDA Product Code

[?]
Product Code Product Code Name
LTI Implant, Intragastric For Morbid Obesity
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P000008 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Do not use if package is damaged and consult instructions for use
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9247d222-c00f-4a41-8d61-68e1d694eea9
January 19, 2024
5
April 01, 2021
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00850007764333 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
844-937-7374
CustomerService@ReShapelifesci.com
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