FDA UDI In Commercial Distribution 🇺🇸 United States

Sleeve for extraoral X-Ray devices

DI: E27633140722 · Model: 3314072 · SIRONA Dental Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500

Basic Information

Brand Name
Sleeve for extraoral X-Ray devices
Primary DI
E27633140722
Version / Model
3314072
Company Name
SIRONA Dental Systems GmbH
Labeler DUNS
340306351
Distribution Status
In Commercial Distribution
Device Count in Pkg
500
Record Status
Published
Publish Date
2016-09-10
Public Version
6
Public Version Date
2023-09-14
Public Version Status
Update
Public Device Record Key
1b6cfe29-da17-4f28-8e81-44adad37e41b

Device Description

Hygienic protective sleeve f. bite block

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OAS X-Ray, Tomography, Computed, Dental

GMDN Terms

Code Name
44245 Stationary panoramic/tomographic dental x-ray system, digital

Identifiers

Type ID
Primary E27633140722
Unit of Use E27633140720

Customer Contacts

Phone
+4962511670