DEVICE: TM "Rehabilitimed" GR-3P L Comfort (04823097719817)

Device Identifier (DI) Information

TM "Rehabilitimed" GR-3P L Comfort
GR-3P L Comfort
In Commercial Distribution
GR-3P L Comfort
REABILITIMED TOV
04823097719817
GS1

1
364875768 *Terms of Use
It is an inguinal hernia bandage, with a front fastener, beige in 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).
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
IPW Orthosis, Sacroiliac, Soft
CLOSE

FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Hip circumference below the waistline by 10 cm (cm): 97-105
CLOSE

Device Record Status

20f96653-b36d-4103-9a30-974663ab98b2
May 13, 2025
1
May 05, 2025
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
835 5030395
Krut.Lora@gmail.com
+380965139983
shenyalipinskiy@gmail.com
+380937042825
reabilitimed@ukr.net
CLOSE