FDA UDI In Commercial Distribution 🇺🇸 United States

SI-1015 Implantmed DSI

DI: J021302890031 · Model: 30289003 · W & H Dentalwerk Bürmoos GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
SI-1015 Implantmed DSI
Primary DI
J021302890031
Version / Model
30289003
Company Name
W & H Dentalwerk Bürmoos GmbH
Labeler DUNS
300238441
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-11
Public Version
1
Public Version Date
2023-07-19
Public Version Status
New
Public Device Record Key
e3a62110-2fd9-40dd-a6f9-ad46df2f27f4

Device Description

Surgical Unit 120 V

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBW Controller, Foot, Handpiece And Cord

GMDN Terms

Code Name
41264 Surgical power tool system control unit, line-powered

Identifiers

Type ID
Direct Marking J021302890030
Primary J021302890031