SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE - A device designed to determine the appropriate - FCI S A S FCI 20 22

Duns Number:763408366

Device Description: A device designed to determine the appropriate size and placement of a non-dental implant A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.

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More Product Details

Catalog Number

-

Brand Name

SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE

Version/Model Number

S6.3060

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

HPZ

Product Code Name

Implant, Eye Sphere

Device Record Status

Public Device Record Key

93bc0876-15da-4c2a-bd25-044ebd872684

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 30, 2021

Additional Identifiers

Package DI Number

13760087123712

Quantity per Package

1

Contains DI Package

03760087123715

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FCI S A S FCI 20 22" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 291
U Unclassified 60