AccessGUDID - DEVICE: TM "Rehabilitimed" GR-3P XL Comfort (04823097717776)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 04823097717776
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: It is an inguinal hernia bandage, with a front fastener, graphite color. It is made of elastic fabric and multilayer material (special velor fabric tripled (glued in a special way with polyurethane foam) with cotton terry cloth), equipped with pockets for pads and an additional inguinal belt with fasteners. The bandage is fastened using textile fasteners on the belt. The pads are installed in the pocket of the bandage on one or both sides (depending on the location of the hernia).

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?
63496	Pelvic fracture binder, single-use	A belt-like support designed to be wrapped tightly around the pelvis (around the greater trochanters) of a patient suspected of a pelvic fracture to support the pelvis during transportation. Sometimes referred to as a pelvic belt or sling, it is typically intended to be used in an emergency setting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPW	Orthosis, Sacroiliac, Soft

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: Hip circumference below the waistline by 10 cm (cm): 105-115

Device Record Status

Public Device Record Key: cc5117dc-bcd2-422b-ac65-a565b44275fc
Public Version Date: May 13, 2025
Public Version Number: 1
DI Record Publish Date: May 05, 2025