HYGITECH - E-LC1 surgery tip compatible with - HYGITECH

Duns Number:279456896

Device Description: E-LC1 surgery tip compatible with EMSHYGITECHReference: HY-98221Flat cutting chisel for ex E-LC1 surgery tip compatible with EMSHYGITECHReference: HY-98221Flat cutting chisel for extraction. Insert mainly used in root osteoplasty. It allows to penetrate deeply and with caution along the alveolar ligament (desmodontium), between the bone and the alveolar rootLength: 9 mm

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More Product Details

Catalog Number

HY-98221

Brand Name

HYGITECH

Version/Model Number

HY-98221

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)

-

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

EJB

Product Code Name

Handle, Instrument, Dental

Device Record Status

Public Device Record Key

88523642-b2e7-4331-85ac-4206d21aeaf1

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HYGITECH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 87
2 A medical device with a moderate to high risk that requires special controls. 8