PHANTOM MULTI-BITE KERRISON RONGEUR - MULTI-BITE KERRISON RONGEUR 3 MM BITE SIZE, 14 MM - Morpheus AG

Duns Number:315142027

Device Description: MULTI-BITE KERRISON RONGEUR 3 MM BITE SIZE, 14 MM OPEN, 200 MM (7.9") LENGTH, SINGLE-USE, MULTI-BITE KERRISON RONGEUR 3 MM BITE SIZE, 14 MM OPEN, 200 MM (7.9") LENGTH, SINGLE-USE, STERILE

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More Product Details

Catalog Number

-

Brand Name

PHANTOM MULTI-BITE KERRISON RONGEUR

Version/Model Number

KR-2003

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

HAE

Product Code Name

Rongeur, Manual

Device Record Status

Public Device Record Key

2eec8728-b7bb-439b-b88b-f17e59b64db7

Public Version Date

July 06, 2022

Public Version Number

1

DI Record Publish Date

June 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MORPHEUS AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 14