AccessGUDID - DEVICE: LAP-BAND (10811955020411)

GUDID

Device Identifier (DI) Information

Brand Name: LAP-BAND
Version or Model: B-20301
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B-20301
Company Name: Apollo Endosurgery, Inc.

Primary DI Number: 10811955020411
Issuing Agency: GS1
Commercial Distribution End Date: December 17, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 625064352 *Terms of Use

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:	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ba8d8fd-5ee6-4ad6-bb4a-9a03dd06a88e
Public Version Date: December 30, 2021
Public Version Number: 6
DI Record Publish Date: August 17, 2016