FDA.reportPublic FDA data

Contour, CoolFit CoolAdvantage

Primary DI
00816417020605
Brand
Contour, CoolFit CoolAdvantage
Company
Zeltiq Aesthetics, Inc.
Model
BRZ-CN3-160-000
Catalog number
BRZ-CN3-160-000
Device description
Contour, CoolFit CoolAdvantage
Published
2016-09-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOKDermal Cooling Pack/Vacuum/Massager

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOKDermal Cooling Pack/Vacuum/MassagerGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816417020605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816417020605008164170206058164170206050816417020605

GMDN Terms#

Term, Definition table
TermDefinition
Cryolipolysis body contouring systemAn assembly of devices designed to non-invasively apply cold to the skin and subcutaneous tissues for subcutaneous fat layer reduction through cold-assisted lipolysis (coolsculpting); it may additionally be used to provide local anaesthesia for procedures that produce minor discomfort. It primarily consists of a mains electricity (AC-powered) control unit to produce the thermal energy, and an applicator and gel pad to convey the thermal energy to the target area (e.g., chin, hips, abdomen, thighs); additional components may be included (e.g., disposable liner for the applicator, electronic program cards, pager).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-935-8471support@zeltiq.com

Regulatory Flags#

DUNS number
809152916
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
00816417022555CoolSculpting EliteCS-SG-S18-01-002026-05-22
00816417022579CoolSculpting EliteCS-FB-185-01-002026-05-22
00816417023088CoolSculpting EliteCS-A3018S-002026-05-22
00816417023538CoolSculpting EliteCS-GL-XLG-10-002026-05-22
10816417020152CoolSmooth Foam Borders BRZ-FB1-09X-024 BRZ-FB1-09X-0242016-09-23
10816417020541CoolSmooth Securement SystemBRZ-SS1-09X-012BRZ-SS1-09X-0122016-09-23
10816417020558CoolSmooth Securement SystemBRZ-SS2-09X-012BRZ-SS2-09X-0122016-09-23
10816417020565CoolSmooth PRO Securement StrapsBRZ-SS3-09X-012BRZ-SS3-09X-0122016-09-23
10816417020671CoolAdvantage GasketBRZ-LN2-160-024BRZ-LN2-160-0242016-09-23
10816417020916CoolAdvantage Petite Gasket - 24 PackBRZ-LN1-140-024BRZ-LN1-140-0242017-03-15
00816417022746Curve 135 (C135) ApplicatorCS-A3-13C-00CS-A3-13C-002024-03-26
00816417021008CoolCurve ApplicatorBRZ-AP1-062-000BRZ-AP1-062-0002021-08-12
00816417021329CoolSculpting Applicator Cable Support ArmBRZ-RP1-ARM-001BRZ-RP1-ARM-0012021-08-06
00816417021350CoolAdvantage Petite Comfort StrapBRZ-SS1-140-002BRZ-SS1-140-0022021-08-06
00816417022739CoolMini Support Arm SystemBRZ-RP2-ARM-001BRZ-RP2-ARM-0012021-08-06
00816417023064CoolMini Securement StrapsBRZ-SS7-02X-002BRZ-SS7-02X-0022021-08-06
00816417022586CoolSculpting Umbilical Cable Assembly 2.3mCS-A3-UM3-00CS-A3-UM3-002021-06-15
00816417022593CoolSculpting Umbilical Cable Assembly 2.6mCS-A3-UM4-00CS-A3-UM4-002021-06-15
00816417021664CoolSculpting Securement System Straps-SmallCS-SS-SM-02-00CS-SS-SM-02-002021-04-30
00816417022432SPP Device, DermalinfusionA0029A00292021-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816417022555CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417022579CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417023088CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417023538CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417022746Curve 135 (C135) ApplicatorZeltiq Aesthetics, Inc.OOK2024-03-26
00816417021008CoolCurve ApplicatorZeltiq Aesthetics, Inc.OOK2021-08-12
00816417021329CoolSculpting Applicator Cable Support ArmZeltiq Aesthetics, Inc.OOK2021-08-06
00816417021350CoolAdvantage Petite Comfort StrapZeltiq Aesthetics, Inc.OOK2021-08-06
00816417022739CoolMini Support Arm SystemZeltiq Aesthetics, Inc.OOK2021-08-06
00816417023064CoolMini Securement StrapsZeltiq Aesthetics, Inc.OOK2021-08-06
00816417022586CoolSculpting Umbilical Cable Assembly 2.3mZeltiq Aesthetics, Inc.OOK2021-06-15
00816417022593CoolSculpting Umbilical Cable Assembly 2.6mZeltiq Aesthetics, Inc.OOK2021-06-15
00816417021664CoolSculpting Securement System Straps-SmallZeltiq Aesthetics, Inc.OOK2021-04-30
00816417022609CoolSculpting Elite Card, Direct, US/CA, Solo,50TxZeltiq Aesthetics, Inc.OOK2021-04-30
00816417022630CoolSculpting Elite Securement Grip, S150Zeltiq Aesthetics, Inc.OOK2021-04-30
00816417022333CoolSculpting Elite Card, Direct, USA, CAN 10 Dual TXZeltiq Aesthetics, Inc.OOK2021-01-31
00816417022449CoolSculpting Elite Card, NFS, Direct, USA, CAN Solo 4 TxZeltiq Aesthetics, Inc.OOK2021-01-31
00816417022456CoolSculpting Elite Card, NFS, Direct, USA,CAN, Dual 4 TxZeltiq Aesthetics, Inc.OOK2021-01-31
00816417022463CoolSculpting Elite Card, Direct, USA, CAN 50 Dual TXZeltiq Aesthetics, Inc.OOK2021-01-31
00816417021343CoolSculpting Elite Quick-Check Card, 99 cycleZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021381CoolSculpting Elite Card, Direct, USA,CAN 20 Solo TrxZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021527CoolSculpting Quad Comfort StrapZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021749CoolSculpting Elite Card, Direct, USA, CAN, 25 Dual TXZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021756CoolSculpting Elite Card, Direct, USA, CAN 100 Solo TXZeltiq Aesthetics, Inc.OOK2020-12-09
00816417022302Foam Borders, S150 ApplicatorZeltiq Aesthetics, Inc.OOK2020-12-09
00816417022319S150 LinerZeltiq Aesthetics, Inc.OOK2020-12-09
00816417022470CoolSculpting Elite Card, Solo,NSF, ZA20-002Zeltiq Aesthetics, Inc.OOK2020-12-09
00816417021718CoolSculpting System Applicator Surface 150 (S150)Zeltiq Aesthetics, Inc.OOK2020-10-31
00816417021473CoolAdhesive Gel Pad (Small)Zeltiq Aesthetics, Inc.OOK2020-08-31
00816417021497CoolAdhesive Gel Pad (Medium)Zeltiq Aesthetics, Inc.OOK2020-08-31