PEAK FX™BARREL HOLDING FORCEPS - Biomet Orthopedics, LLC

Duns Number:129278169

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More Product Details

Catalog Number

214204034

Brand Name

PEAK FX™BARREL HOLDING FORCEPS

Version/Model Number

2142-04-034

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

GEN

Product Code Name

FORCEPS, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

62428ca1-7777-491f-9a0d-54e9b88db760

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

April 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET ORTHOPEDICS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11962
2 A medical device with a moderate to high risk that requires special controls. 28376
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4