FDA UDI In Commercial Distribution 🇺🇸 United States

SCHICK ELITE

DI: D76464042351 · Model: 6404235 · SIRONA DENTAL, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
SCHICK ELITE
Primary DI
D76464042351
Version / Model
6404235
Company Name
SIRONA DENTAL, INC.
Labeler DUNS
078613913
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-09
Public Version
4
Public Version Date
2022-12-09
Public Version Status
Update
Public Device Record Key
ee4323de-e79a-49d7-8938-9b797ed01414

Device Description

USB REMOTE HS / ELITE CABLE (2 METER)

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MUH System,X-Ray,Extraoral Source,Digital
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
EHD Unit, X-Ray, Extraoral With Timer

GMDN Terms

Code Name
60743 Medical device USB cable

Identifiers

Type ID
Primary D76464042351

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K072134 000