CRYOGEN CANISTER - Cryogen Canister, R134a, can, ea - VIVEVE, INC.

Duns Number:025398094

Device Description: Cryogen Canister, R134a, can, ea

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More Product Details

Catalog Number

VIVCC03

Brand Name

CRYOGEN CANISTER

Version/Model Number

VIVCC03

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

K082962,K082962

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

5a3ddc9d-8728-444a-b893-72e22e7adabc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

10850794007054

Quantity per Package

4

Contains DI Package

00850794007057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"VIVEVE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12