FDA.reportPublic FDA data

CRYOGEN CANISTER

Primary DI
10850794007054
Brand
CRYOGEN CANISTER
Company
VIVEVE, INC.
Model
VIVCC03
Catalog number
VIVCC03
Device description
Cryogen Canister, R134a, can, ea
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082962000TIVAMED COOLED RF SYSTEM, MODEL 78001Tivamed, Inc.2008-12-04GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850794007054PackageGS14In Commercial Distribution
00850794007057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085079400705410850794007054
00850794007057008507940070578507940070570850794007057

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
025398094
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008507940070025 cm Treatment TipVIVTT05VIVTT052016-09-23
008507940070195 cm Treatment Tip SVIVTT06VIVTT062016-09-23
008507940070268 cm Treatment TipVIVTT07VIVTT072016-09-23
00850794007057CRYOGEN CANISTERVIVCC03VIVCC032016-10-03
00850794007071COUPLING FLUIDVIVCF02VIVCF022016-10-03
00850794007088VIVEVE Hand PieceVIVHP01VIVHP012016-09-23
00850794007101VIVEVE Hand Piece SVIVHP01SVIVHP01S2016-09-23
00850794007118VIVEVE ConsoleVIVGE01VIVGE012016-09-23
00850794007132VIVEVE Console SVIVGE01SVIVGE01S2016-09-23
00850794007163Universal Electrosurgical Pad (3M REF 9160) VIVRP02VIVRP022016-10-03
00850794007170VIVEVE FootswitchVIVFS01VIVFS012016-09-23
00850794007187VIVEVE Power CordVIVPC0XVIVPC0X2016-10-03
00850794007194VIVEVE Return CableVIVRC01VIVRC012016-10-03
108507940070095 cm Treatment TipVIVTT05VIVTT052016-09-23
108507940070165 cm Treatment Tip SVIVTT06VIVTT062016-09-23
108507940070238 cm Treatment TipVIVTT07VIVTT072016-09-23
10850794007078COUPLING FLUIDVIVCF02VIVCF022016-10-03

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