Bending Forceps, Large & Small Fragment PRS - I.T.S. GmbH

Duns Number:303456917

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More Product Details

Catalog Number

-

Brand Name

Bending Forceps, Large & Small Fragment PRS

Version/Model Number

64007

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

HXP

Product Code Name

Instrument, Bending Or Contouring

Device Record Status

Public Device Record Key

d76bd883-065b-4638-b831-8624bf3c27ff

Public Version Date

October 27, 2022

Public Version Number

1

DI Record Publish Date

October 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"I.T.S. GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 410
2 A medical device with a moderate to high risk that requires special controls. 1463