FDA UDI
In Commercial Distribution
🇺🇸 United States
CoolSculpting Elite
DI: 00816417022487
·
Model: CS-CS-D01-01-00
·
Zeltiq Aesthetics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CoolSculpting Elite
- Primary DI
- 00816417022487
- Version / Model
- CS-CS-D01-01-00
- Company Name
- Zeltiq Aesthetics, Inc.
- Labeler DUNS
- 809152916
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-27
- Public Version
- 1
- Public Version Date
- 2026-04-06
- Public Version Status
- New
- Public Device Record Key
- 89188c6a-2adc-4cf4-bd93-1981c2d7464c
Device Description
Card, ELITE, NFS, D, US/CA, Solo, 1Tx
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OOK | Dermal Cooling Pack/Vacuum/Massager | General, Plastic Surgery | 878.4340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56309 | Cryolipolysis body contouring system applicator | A component of a cryolipolysis body contouring system designed to convey controlled cold from the system's control unit to the skin and subcutaneous tissues for cold-assisted lipolysis (coolsculpting). It is typically in the form of an articulated arm designed to hold a gel pad against the surface of the treatment site, and may also be used to apply vacuum to facilitate the treatment; optional pulsatile massage may also be applied. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816417022487 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233732 | 000 |