E6502N Hose Cover 15x221cm - EXACT MEDICAL MANUFACTURING, INC.

Duns Number:014464314

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More Product Details

Catalog Number

-

Brand Name

E6502N Hose Cover 15x221cm

Version/Model Number

E6502N

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

97b33387-14c1-444a-859d-91ba8aebd5fe

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 27, 2016

Additional Identifiers

Package DI Number

00816953029315

Quantity per Package

100

Contains DI Package

00816953029308

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