FDA UDI In Commercial Distribution 🇺🇸 United States

PinPointe FootLaser

DI: 00869080000207 · Model: 7005 · NUVOLASE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PinPointe FootLaser
Primary DI
00869080000207
Version / Model
7005
Company Name
NUVOLASE INC.
Labeler DUNS
078274442
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-10-02
Public Version
2
Public Version Date
2020-02-06
Public Version Status
Update
Public Device Record Key
22419557-735a-4789-a927-f88c54f30174

Device Description

Short pulsed Nd:YAG laser

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GEX Powered Laser Surgical Instrument

GMDN Terms

Code Name
47883 Dermatological solid-state laser system

Identifiers

Type ID
Primary 00869080000207