AccessGUDID - DEVICE: Unite Medical® (00850012035572)

GUDID

Device Identifier (DI) Information

Brand Name: Unite Medical®
Version or Model: Lumbar Sacral Orthosis (Universal)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LSO3750
Company Name: Unite Medical, LLC

Primary DI Number: 00850012035572
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117553945 *Terms of Use

Device Description: The Unite Medical® Lumbar Sacral Orthosis is a universal, lightweight spinal orthosis offering anterior, posterior and lateral support.

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):	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?
33031	Lumbar spine orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQE	Orthosis, Lumbar

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: ed8ddffa-12c0-43ca-adfa-2f1733728ac5
Public Version Date: January 05, 2024
Public Version Number: 1
DI Record Publish Date: December 28, 2023