ELMED - ARTHROSCOPE, STRYKER, 4MM 45* - PROGRESSIVE MEDICAL INSTRUMENTATION INC

Duns Number:131054074

Device Description: ARTHROSCOPE, STRYKER, 4MM 45*

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More Product Details

Catalog Number

PMI23-40045STR

Brand Name

ELMED

Version/Model Number

PMI23-40045STR

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

NBH

Product Code Name

Accessories, Arthroscopic

Device Record Status

Public Device Record Key

dd8ebfbf-2d13-40a0-8980-c9e9b5e64ce2

Public Version Date

December 16, 2019

Public Version Number

1

DI Record Publish Date

December 06, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROGRESSIVE MEDICAL INSTRUMENTATION INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 41