1/2 Gracey - Berman Instruments LLC

Duns Number:118744340

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More Product Details

Catalog Number

-

Brand Name

1/2 Gracey

Version/Model Number

CG012

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

KAP

Product Code Name

Curette, Nasal

Device Record Status

Public Device Record Key

70050e93-e74d-4079-aada-4865998a0755

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BERMAN INSTRUMENTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 161