Medline - AR-9606H-90 OPES ARTSPC ELTD,90 DEGREE - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: AR-9606H-90 OPES ARTSPC ELTD,90 DEGREE

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

AR9606H90RH

Brand Name

Medline

Version/Model Number

AR9606H90RH

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

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

c6f0fa7e-85d1-45d4-a3d0-f9ee539ee050

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

September 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7