High Density 144 Sublative iD (200 Pulse), 10-Pk - High Density 144 Sublative iD (200 Pulse), 10-Pk - SYNERON MEDICAL LTD

Duns Number:532685716

Device Description: High Density 144 Sublative iD (200 Pulse), 10-Pk

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More Product Details

Catalog Number

KT72921

Brand Name

High Density 144 Sublative iD (200 Pulse), 10-Pk

Version/Model Number

KT72921

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090025

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

95dc4708-406b-4a2d-b090-bc3b7973b7a6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNERON MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 194