H.A.S.® - ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Duns Number:137354267

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More Product Details

Catalog Number

-

Brand Name

H.A.S.®

Version/Model Number

00-2555-030-05

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

K920273,K920273

Product Code Details

Product Code

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Device Record Status

Public Device Record Key

b71b82b7-9fab-431c-9bcc-5f094823176e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

00889024021624

Quantity per Package

5

Contains DI Package

00889024021570

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1447
2 A medical device with a moderate to high risk that requires special controls. 96