Faset - Implant Caddy Case for 5.0 - DIOMEDICAL CO.,LTD.

Duns Number:557795909

Device Description: Implant Caddy Case for 5.0

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More Product Details

Catalog Number

FA.CS.0050

Brand Name

Faset

Version/Model Number

A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K180729

Product Code Details

Product Code

MRW

Product Code Name

SYSTEM, FACET SCREW SPINAL DEVICE

Device Record Status

Public Device Record Key

decbea9e-ab37-47d7-8751-d1a7cad9cc6b

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIOMEDICAL CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7203
U Unclassified 227