AccessGUDID - DEVICE: Motiva® Inflatable Balloon (07445161009579)

GUDID

Device Identifier (DI) Information

Brand Name: Motiva® Inflatable Balloon
Version or Model: MIB-0090
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MIB-0090
Company Name: Establishment Labs S.A.

Primary DI Number: 07445161009579
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 853166098 *Terms of Use

Device Description: Motiva® Inflatable Balloon - 9 cm base

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?
65237	Invasive breast implant sizer, inflatable	A manual inflatable device intended to be inserted intraoperatively into a tissue pocket surgically-created for the acceptance of a breast augmentation implant, to ascertain that sufficient space has been created for the placement of the implant. It is a balloon-like device connected to a manually-powered air pump used to expand the device; devices associated with the sizer introduction may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZW	Expander, Surgical, Skin Graft

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: 782cec6a-52cc-4e16-9c8d-1a5a0cff6eeb
Public Version Date: June 16, 2025
Public Version Number: 1
DI Record Publish Date: June 06, 2025