E6560 Light Handle Cover Rigid 7cm - 2,8" - EXACT MEDICAL MANUFACTURING, INC.

Duns Number:014464314

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More Product Details

Catalog Number

-

Brand Name

E6560 Light Handle Cover Rigid 7cm - 2,8"

Version/Model Number

E6560

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KKX

Product Code Name

Drape, Surgical

Device Record Status

Public Device Record Key

23f1a072-d63a-4dcc-bc24-148459b8aa0e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 28, 2016

Additional Identifiers

Package DI Number

00852205007236

Quantity per Package

80

Contains DI Package

00852205007229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"EXACT MEDICAL MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 489