AccessGUDID - DEVICE: PRO PELVIC SPLINT (M68955110010)

GUDID

Device Identifier (DI) Information

Brand Name: PRO PELVIC SPLINT
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 55-110
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68955110010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: PRO PELVIC SPLINT 1 ea - 6 mm Neoprene Band, 1 ea - Black Velcro Straps with Buckle Intended for the emergency management of suspected pelvic fracture(s).

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:	Yes
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?
63255	Pelvic fracture binder, reusable	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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HSQ	Belt, Pelvic, Traction

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: 0166f11a-0858-48d8-9de4-b4b3dbd9fb6a
Public Version Date: January 20, 2023
Public Version Number: 4
DI Record Publish Date: May 25, 2018