Synergetics - 20ga Stellaris PC Mid-Field Endoilluminator - SYNERGETICS USA, INC.

Duns Number:021056726

Device Description: 20ga Stellaris PC Mid-Field Endoilluminator

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More Product Details

Catalog Number

BL5820M

Brand Name

Synergetics

Version/Model Number

BL5820M

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

Yes

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

MPA

Product Code Name

Endoilluminator

Device Record Status

Public Device Record Key

f94d3e7a-da50-4497-b84c-9a087547f31b

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

June 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNERGETICS USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 336
2 A medical device with a moderate to high risk that requires special controls. 47