FDA.report

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
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications

CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B911Y30000PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
1-877-451-3000les@pelvicbinder.com

Regulatory Flags

DUNS number
127609332
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B911PED4X300Pelvic BinderPED4x30PED4x302021-12-27

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