HEARTLINE RETRACTOR FRAME - HEARTLINE RETRACTOR FRAME WITH INSERTS - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: HEARTLINE RETRACTOR FRAME WITH INSERTS

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More Product Details

Catalog Number

2800-801

Brand Name

HEARTLINE RETRACTOR FRAME

Version/Model Number

2800-801

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"

Yes

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

FFO

Product Code Name

RETRACTOR, SELF-RETAINING

Device Record Status

Public Device Record Key

6edba634-4edb-4c53-8cd8-de652b50a54c

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

March 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414