AUX. BASE CONNECTOR KIT - AUX. BASE CONNECTOR KIT 3100/A & NEW N'S - SKYTRON LLC

Duns Number:078375583

Device Description: AUX. BASE CONNECTOR KIT 3100/A & NEW N'S

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More Product Details

Catalog Number

-

Brand Name

AUX. BASE CONNECTOR KIT

Version/Model Number

D5-060-24

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

LWG

Product Code Name

Surgical Table Cushion

Device Record Status

Public Device Record Key

5332a6a7-defc-4076-85f4-f9995da8e076

Public Version Date

October 23, 2019

Public Version Number

1

DI Record Publish Date

October 15, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SKYTRON LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 747
2 A medical device with a moderate to high risk that requires special controls. 265