AccessGUDID - DEVICE: TM "Rehabilitimed" S-3M XL Comfort (04823097716762)

GUDID

Device Identifier (DI) Information

Brand Name: TM "Rehabilitimed" S-3M XL Comfort
Version or Model: S-3M XL Comfort
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S-3M XL Comfort
Company Name: REABILITIMED TOV

Primary DI Number: 04823097716762
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: It is a surgical bandage for the abdominal wall, beige in color. The part of the bandage adjacent to the back and the right front-side parts that perform fixation are made of elastic bandage fabric, and the left front-side part located on the abdomen is made of multilayer material (special velor fabric tripled (glued in a special way with polyurethane foam) with cotton terry cloth), with 2 plastic stiffening ribs. The versatility of the bandage lies in the presence of two front-side elastic ties instead of the front-side part made of solid elastic cloth and is specially designed for patients with a large difference in the volume of the waist and hips. The height of the corset is 24 cm.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
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
KTD	Orthosis, 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
Device Size Text, specify: Hips 10 cm below the waistline (cm): 103-112
Device Size Text, specify: Bandage length (cm): 122-126

Device Record Status

Public Device Record Key: 7068205d-b590-42de-909f-3888116ba090
Public Version Date: May 12, 2025
Public Version Number: 1
DI Record Publish Date: May 04, 2025