Buxton Wrist Retractor Blade, 15mm Assy, Net - 30mm x 15mm radiolucent carbon fiber retractor - COMPOSITE MANUFACTURING, INC.

Duns Number:947090650

Device Description: 30mm x 15mm radiolucent carbon fiber retractor

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More Product Details

Catalog Number

-

Brand Name

Buxton Wrist Retractor Blade, 15mm Assy, Net

Version/Model Number

1-8001-215-001

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)

-

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

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

976212cf-8250-4413-805b-12c36beb5756

Public Version Date

April 21, 2021

Public Version Number

1

DI Record Publish Date

April 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMPOSITE MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 1