Pelvic Binder, Inc.

FDA UDI

Class I (US FDA UDI)

by Pelvic Binder, Inc.

Identity

Trade Name: Pelvic Binder, Inc. FDA UDI
Generic Name: Pelvic fracture binder, single-use FDA UDI
Device Name: 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. FDA UDI
Model / Reference: Y3000 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: Y3000 FDA UDI
Primary DI / UDI-DI: B911Y30000 FDA UDI
FDA Product Code: MRI FDA UDI
GMDN Term: Pelvic fracture binder, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3490 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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MRI Safety

MR Safe FDA UDI

Category: Pelvic fracture binder, single-use

Pelvic Binder, Inc. by Pelvic Binder, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Pelvic Binder, Inc.

Sources (1)

FDA UDI 1b502efa-b1b6-46b7-9801-ecc6beaa7290 35 fields · synced Jun 9, 2026