FDA UDI
In Commercial Distribution
🇺🇸 United States
Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
DI: 00817495024547
·
Model: KT77821
·
Candela Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
- Primary DI
- 00817495024547
- Version / Model
- KT77821
- Catalog Number
- KT77821
- Company Name
- Candela Corporation
- Labeler DUNS
- 053468385
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-20
- Public Version
- 1
- Public Version Date
- 2023-10-30
- Public Version Status
- New
- Public Device Record Key
- 9764a55e-61ec-4f7c-840a-49cbc32ca46c
Device Description
Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45221 | Dermatological laser beam guiding handpiece | A hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817495024547 | GS1 | ||||
| Previous | 17290109952724 | GS1 |
Customer Contacts
- Phone
- 8007352737
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181523 | 000 |