AccessGUDID - DEVICE: LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) (10850007764330)

GUDID

Device Identifier (DI) Information

Brand Name: LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)
Version or Model: B-20301-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B-20301-10
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 10850007764330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 022894714 *Terms of Use
Previous DI: 10811955020411

Device Description: LAP-BAND® Access Port Needle 3.5 inch Pouch

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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
No Device Sizes

Device Record Status

Public Device Record Key: 9247d222-c00f-4a41-8d61-68e1d694eea9
Public Version Date: January 19, 2024
Public Version Number: 5
DI Record Publish Date: April 01, 2021