AccessGUDID - DEVICE: ReShape™ Removal Catheter (B001RSM2101)

GUDID

Device Identifier (DI) Information

Brand Name: ReShape™ Removal Catheter
Version or Model: RSM210
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RSM210
Company Name: RESHAPE MEDICAL, INC.

Primary DI Number: B001RSM2101
Issuing Agency: HIBCC
Commercial Distribution End Date: April 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 877283486 *Terms of Use

Device Description: ReShape™ Removal Catheter - component to remove the ReShape™ Integrated Dual Balloon

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
46678	Flexible endoscopic biopsy handpiece/needle	A sterile flexible device intended to be used to obtain tissue specimens, for histopathological examination, during various endoscopic procedures (e.g., bronchoscopy, gastroscopy). It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a biopsy needle which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the compatible endoscope. 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: 62f9a69e-3ef8-4e0f-a283-d21464ca9e8b
Public Version Date: July 28, 2023
Public Version Number: 6
DI Record Publish Date: August 25, 2015