FDA UDI In Commercial Distribution 🇺🇸 United States

Glace

DI: 00817495025391 · Model: FIN104594 · Candela Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
Glace
Primary DI
00817495025391
Version / Model
FIN104594
Company Name
Candela Corporation
Labeler DUNS
053468385
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-10-07
Public Version
1
Public Version Date
2025-10-15
Public Version Status
New
Public Device Record Key
30b7a4a8-3fc1-4f95-98bf-a22c03e86298

Device Description

Glace VACUUM CUPPING HANDPIECE PACKAGE

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GFE Brush, Dermabrasion, Powered

GMDN Terms

Code Name
47983 Pressure-wave skin contouring system applicator, pneumatic

Identifiers

Type ID
Primary 00817495025391