FDA.reportPublic FDA data

Pelvic Binder

Primary DI
B911PED4X300
Brand
Pelvic Binder
Company
Pelvicbinder, Inc
Model
PED4x30
Catalog number
PED4x30
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.
Published
2021-12-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B911PED4X300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic binder, single-useA non-sterile, 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. It is typically intended to be used in an emergency setting to stabilize pelvic fractures. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-451-3000les@pelvicbinder.com

Regulatory Flags#

DUNS number
127609332
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B911Y30000Pelvic Binder, Inc.Y3000Y30002021-12-27

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