SureTrans Autotransfusion System for Orthopaedics - SureTrans Autotransfusion System for Orthopaedics - Davol Inc.

Duns Number:001191048

Device Description: SureTrans Autotransfusion System for Orthopaedics with PVC Drain and 2 Trocars

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More Product Details

Catalog Number

8592000

Brand Name

SureTrans Autotransfusion System for Orthopaedics

Version/Model Number

8592000

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

Yes

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

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Device Record Status

Public Device Record Key

41651ccd-8d28-4713-bf6e-849ece5ac2e6

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

June 17, 2015

Additional Identifiers

Package DI Number

10801741065412

Quantity per Package

6

Contains DI Package

00801741065415

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"DAVOL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 348
3 A medical device with high risk that requires premarket approval 18