AccessGUDID - DEVICE: M-Brace Air (05391512284305)

GUDID

Device Identifier (DI) Information

Brand Name: M-Brace Air
Version or Model: 515 M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 515
Company Name: INDACO SRL

Primary DI Number: 05391512284305
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
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?
47217	Abdominal binder, reusable	A strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSD	Binder, Abdominal

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: No
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: e632efc2-37a1-4f27-b1f7-4b2a93d99ece
Public Version Date: March 01, 2024
Public Version Number: 1
DI Record Publish Date: February 22, 2024