FDA UDI Not in Commercial Distribution 🇺🇸 United States

OT EQUATOR-OT BRIDGE

DI: D821130NCM3 · Model: OT EQUATOR NEODENT CM h.3 · 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
D821130NCM3
Version / Model
OT EQUATOR NEODENT CM h.3
Catalog Number
130NCM3
Company Name
RHEIN 83 SRL
Labeler DUNS
439240722
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-18
Public Version
2
Public Version Date
2021-01-28
Public Version Status
Update
Public Device Record Key
17b1d757-cea1-42b9-9cb7-a3723f31f529
Distribution End Date
2021-01-27

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
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
Yes

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
47829 Surgical instrument handle, non-torque-limiting

Identifiers

Type ID
Primary D821130NCM3