FDA UDI In Commercial Distribution 🇺🇸 United States

Double diameter drill D3,8/3,4x11,5mm RealGUIDE Z3D Kit

DI: 08050038831642 · Model: 3DM00613.38.115ZUS · 3DIEMME SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Double diameter drill D3,8/3,4x11,5mm RealGUIDE Z3D Kit
Primary DI
08050038831642
Version / Model
3DM00613.38.115ZUS
Company Name
3DIEMME SRL
Labeler DUNS
857172105
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-19
Public Version
1
Public Version Date
2022-12-27
Public Version Status
New
Public Device Record Key
2ebaa949-7850-493a-bca2-a87da03abc8d

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
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
QRQ Non-Irrigation Endosseous Dental Implant Drill Bits

GMDN Terms

Code Name
45147 Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Identifiers

Type ID
Primary 08050038831642