AccessGUDID - DEVICE: ALIMED HIPSHIELD XTRA, 4 PANTS, 1 SET OF PADS (00733657263923)

GUDID

Device Identifier (DI) Information

Brand Name: ALIMED HIPSHIELD XTRA, 4 PANTS, 1 SET OF PADS
Version or Model: 713287/NA/NA/SM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2970009222
Company Name: ALIMED, INC.

Primary DI Number: 00733657263923
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056007248 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	No
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?
36312	Hip protection trousers	A garment intended to be worn over a patient?s hips to provide protection for the protruding hip areas (greater trochanter) and against the possibility of a hip (neck of femur) or femoral shaft fracture in the event of a patient fall. This device is typically available as an undergarment or outer trousers designed with built-in pads or specialized side pockets for the placement of removable firm pads (one on either side) that transfer the energy from the impact of a fall to the soft tissue and muscles anterior and posterior to the femoral bone, thus diverting the force of the impact away from the greater trochanter. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQI	ORTHOSIS, LIMB BRACE

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: 7d18ce8d-2cec-434e-bfe9-6743163a0f4d
Public Version Date: February 19, 2024
Public Version Number: 2
DI Record Publish Date: December 01, 2022