BMI - Abductor Pillow, Double-straps - Blake Manufacturing, Inc.

Duns Number:103449711

Device Description: Abductor Pillow, Double-straps

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More Product Details

Catalog Number

MSC-AP-DS

Brand Name

BMI

Version/Model Number

MSC-AP-DS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

ITQ

Product Code Name

Joint, Knee, External Brace

Device Record Status

Public Device Record Key

0bdf5199-ffec-4321-ad63-3d84526e58c7

Public Version Date

August 30, 2022

Public Version Number

3

DI Record Publish Date

October 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BLAKE MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 325