DeGen Standard Instrumentation - Screw Driver, Cannulated, T25 - DEGEN MEDICAL, INC.

Duns Number:078812602

Device Description: Screw Driver, Cannulated, T25

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More Product Details

Catalog Number

97-32P

Brand Name

DeGen Standard Instrumentation

Version/Model Number

97-32P

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

LXH

Product Code Name

Orthopedic manual surgical instrument

Device Record Status

Public Device Record Key

2f353cef-29c9-4536-8f38-31c39aecdda1

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEGEN MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 511
2 A medical device with a moderate to high risk that requires special controls. 4143