Batrik Pin Guard\.093"\Grey w/sleeve - Pin Guard, .093" (2.36 mm), Grey, Non-sterile, - Batrik Medical Manufacturing Inc

Duns Number:243880700

Device Description: Pin Guard, .093" (2.36 mm), Grey, Non-sterile, with sleeve

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More Product Details

Catalog Number

914-1093-SLV

Brand Name

Batrik Pin Guard\.093"\Grey w/sleeve

Version/Model Number

914-1093-SLV

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

Yes

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

bff4bc4a-d3a7-48f3-b4a5-c432fe3f7f6d

Public Version Date

November 05, 2021

Public Version Number

1

DI Record Publish Date

October 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BATRIK MEDICAL MANUFACTURING INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 748
2 A medical device with a moderate to high risk that requires special controls. 20