VIPER - VIPER F2 FACET FIXATION SYSTEM SCREW 5 x 25mm - Medos International Sàrl

Duns Number:482661753

Device Description: VIPER F2 FACET FIXATION SYSTEM SCREW 5 x 25mm

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More Product Details

Catalog Number

175710525

Brand Name

VIPER

Version/Model Number

175710525

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

K101762

Product Code Details

Product Code

MRW

Product Code Name

SYSTEM, FACET SCREW SPINAL DEVICE

Device Record Status

Public Device Record Key

cdf93b01-a575-4672-b83e-ac66b16f684f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDOS INTERNATIONAL SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 972
2 A medical device with a moderate to high risk that requires special controls. 6382
3 A medical device with high risk that requires premarket approval 20
U Unclassified 20