FDA UDI In Commercial Distribution 🇺🇸 United States

OT EQUATOR-OT BRIDGE

DI: 08059224141886 · Model: ANALOG Ø5 W/SCREW FOR CAD/CAM MODEL · RHEIN 83 SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
OT EQUATOR-OT BRIDGE
Primary DI
08059224141886
Version / Model
ANALOG Ø5 W/SCREW FOR CAD/CAM MODEL
Catalog Number
144AVC5
Company Name
RHEIN 83 SRL
Labeler DUNS
439240722
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-21
Public Version
2
Public Version Date
2021-02-22
Public Version Status
Update
Public Device Record Key
f0d240a7-00f8-4a02-873f-c0a10f679592

Device Description

Device for laboratory use that allows to replicate the position and geometry of the attachment positioned inside the printed model. The prosthetic structure is then created on it.

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
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
No

Product Codes

Code Name
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
44880 Dental implant suprastructure, temporary, preformed, single-use

Identifiers

Type ID
Primary 08059224141886