FDA.reportPublic FDA data

Pelvic Binder, Inc.

Primary DI
B911Y30000
Brand
Pelvic Binder, Inc.
Company
Pelvicbinder, Inc
Model
Y3000
Catalog number
Y3000
Device description
Adult Yellow Pelvic Binder. Soft goods medical brace for stabilizationof 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
B911Y30000PrimaryHIBCC0

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
B911PED4X300Pelvic BinderPED4x30PED4x302021-12-27

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