N/A - TROCAR SHEATH, QUICK-LOCK, 3.8 MM - Henke-Sass, Wolf GmbH

Duns Number:317326411

Device Description: TROCAR SHEATH, QUICK-LOCK, 3.8 MM

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More Product Details

Catalog Number

8300053528

Brand Name

N/A

Version/Model Number

8300053528

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

60dfb725-98f5-4341-9489-00dc364aef6e

Public Version Date

February 26, 2021

Public Version Number

1

DI Record Publish Date

February 18, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HENKE-SASS, WOLF GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 77