FDA UDI Not in Commercial Distribution 🇺🇸 United States

OT EQUATOR-OT BRIDGE

DI: D821131BFT3 · Model: OT EQUATOR STRAUMANN h.3 c/Smart Box · 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
D821131BFT3
Version / Model
OT EQUATOR STRAUMANN h.3 c/Smart Box
Catalog Number
131BFT3
Company Name
RHEIN 83 SRL
Labeler DUNS
439240722
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-16
Public Version
2
Public Version Date
2021-01-21
Public Version Status
Update
Public Device Record Key
d39366cc-0983-493f-b742-8826942ca7ab
Distribution End Date
2021-01-20

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
MR Unsafe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
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
DZE Implant, Endosseous, Root-Form

GMDN Terms

Code Name
44879 Dental implant suprastructure, permanent, preformed

Identifiers

Type ID
Primary D821131BFT3