BOEHRINGER® Arm Restraint Straps ( 1 pair ) - 27 Inches - Arm Restraint Straps ( 1 pair ) - 27 Inches - BOEHRINGER LABORATORIES, LLC

Duns Number:079991657

Device Description: Arm Restraint Straps ( 1 pair ) - 27 Inches

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More Product Details

Catalog Number

9008

Brand Name

BOEHRINGER® Arm Restraint Straps ( 1 pair ) - 27 Inches

Version/Model Number

9008

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

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

FMQ

Product Code Name

Restraint, Protective

Device Record Status

Public Device Record Key

9fb32c66-6ca7-46b4-9462-ccd6061d4651

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

60816286020562

Quantity per Package

2

Contains DI Package

10816286020567

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"BOEHRINGER LABORATORIES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 85