Placement Wrench for LSB Bolts - AD-TECH MEDICAL INSTRUMENT CORPORATION

Duns Number:174813410

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More Product Details

Catalog Number

LSB-PWL-2.4-10X

Brand Name

Placement Wrench for LSB Bolts

Version/Model Number

LSB-PWL-2.4-10X

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

HXC

Product Code Name

WRENCH

Device Record Status

Public Device Record Key

8c121e60-0f29-4303-961f-17bfb8c175ff

Public Version Date

August 17, 2021

Public Version Number

1

DI Record Publish Date

August 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AD-TECH MEDICAL INSTRUMENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 796