MICRUSPHERE CERECYTE - MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE - Medos International Sàrl

Duns Number:482661753

Device Description: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 6mm x 12.2cm 190cm Contents: 1 Detachab MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 6mm x 12.2cm 190cm Contents: 1 Detachable Coil System

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More Product Details

Catalog Number

CSP18060030

Brand Name

MICRUSPHERE CERECYTE

Version/Model Number

CSP180600-30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K082739

Product Code Details

Product Code

HCG

Product Code Name

DEVICE, NEUROVASCULAR EMBOLIZATION

Device Record Status

Public Device Record Key

fec27a52-78d1-4bfc-b7f6-6c8a9e62525c

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 20, 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