4CIS® INSTRUMENT SYSTEM - 4CIS® Chiron XT Fixing Sleeve - SOLCO BIOMEDICAL CO.,LTD.

Duns Number:687844241

Device Description: 4CIS® Chiron XT Fixing Sleeve

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More Product Details

Catalog Number

4901-8112

Brand Name

4CIS® INSTRUMENT SYSTEM

Version/Model Number

4901-8112

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

-

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

524d09bc-9a45-41db-bdb4-995707854499

Public Version Date

October 18, 2022

Public Version Number

1

DI Record Publish Date

October 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOLCO BIOMEDICAL CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 969
2 A medical device with a moderate to high risk that requires special controls. 6429