FDA UDI In Commercial Distribution 🇺🇸 United States

Ergo glide

DI: 00850079280113 · Model: Turbo-AP · Hexa Dental
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ergo glide
Primary DI
00850079280113
Version / Model
Turbo-AP
Company Name
Hexa Dental
Labeler DUNS
096955608
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-21
Public Version
1
Public Version Date
2026-01-29
Public Version Status
New
Public Device Record Key
8bbbec4d-48de-4c2f-96bc-ad3365a42658

Device Description

Hexa Hygenist Prophy Handpiece w/360 degree swivel nose cone (silver )4-hole

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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EGS Handpiece, Contra- And Right-Angle Attachment, Dental

GMDN Terms

Code Name
44776 Electrosurgical system

Identifiers

Type ID
Primary 00850079280113