AccessGUDID - DEVICE: Pelvic Binder (B911PED4X300)

GUDID

Device Identifier (DI) Information

Brand Name: Pelvic Binder
Version or Model: PED4x30
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PED4x30
Company Name: Pelvicbinder, Inc

Primary DI Number: B911PED4X300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 127609332 *Terms of Use

Device Description: Pediatric Yellow Pelvic Binder. Soft goods medical brace for stabilization of fractured pelvis used by physicians in emergency room and paramedics in the pre-hospital environment.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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
MRI	Orthosis, Truncal/Orthosis, Limb

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: ed2a6cc7-f1bf-4e7a-8f88-eae83c64733f
Public Version Date: January 20, 2023
Public Version Number: 2
DI Record Publish Date: December 27, 2021