FDA.reportPublic FDA data

Body Handpiece 15mm

Primary DI
00816417022425
Brand
Body Handpiece 15mm
Company
Zeltiq Aesthetics, Inc.
Model
A0195
Catalog number
A0195
Device description
Body Handpiece 15mm kit
Published
2021-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816417022425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816417022425008164170224258164170224250816417022425

GMDN Terms#

Term, Definition table
TermDefinition
Dermabrasion brush, rotaryA device with wire bristles that is rotated in a power-driven tool to plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
809152916
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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
00816417021510Gel Trap C80CS-GT-08C-10-002020-08-31
00816417022487CoolSculpting EliteCS-CS-D01-01-002026-03-27
00816417023767CoolSculpting Elite299012412026-03-27
00816417022746Curve 135 (C135) ApplicatorCS-A3-13C-00CS-A3-13C-002024-03-26
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
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
00816417021664CoolSculpting Securement System Straps-SmallCS-SS-SM-02-00CS-SS-SM-02-002021-04-30
00816417022630CoolSculpting Elite Securement Grip, S150cs-ss-s15-02-00cs-ss-s15-02-002021-04-30

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