Pelvic Binder, Inc. - Adult Yellow Pelvic Binder. Soft goods medical - Pelvicbinder, Inc

Duns Number:127609332

Device Description: Adult Yellow Pelvic Binder. Soft goods medical brace for stabilizationof fractured pelvis 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.

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More Product Details

Catalog Number

Y3000

Brand Name

Pelvic Binder, Inc.

Version/Model Number

Y3000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MRI

Product Code Name

Orthosis, Truncal/Orthosis, Limb

Device Record Status

Public Device Record Key

1b502efa-b1b6-46b7-9801-ecc6beaa7290

Public Version Date

January 04, 2022

Public Version Number

1

DI Record Publish Date

December 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PELVICBINDER, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2