Lucae Bayonet Ear Forceps - Lucae Bayonet Ear Forceps Quantum - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Lucae Bayonet Ear Forceps Quantum

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More Product Details

Catalog Number

-

Brand Name

Lucae Bayonet Ear Forceps

Version/Model Number

467-310Q

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"

Yes

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

KAE

Product Code Name

FORCEPS, ENT

Device Record Status

Public Device Record Key

79a741c8-e889-4e6d-ae11-4ae149d3d4b7

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414