FDA UDI In Commercial Distribution 🇺🇸 United States

Cable MX LED 3M

DI: J00716008810011 · Model: 1600881-001 · BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Cable MX LED 3M
Primary DI
J00716008810011
Version / Model
1600881-001
Catalog Number
1600881-001
Company Name
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Labeler DUNS
338234588
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-17
Public Version
3
Public Version Date
2022-10-26
Public Version Status
Update
Public Device Record Key
9251c44d-e115-45e4-9ef8-4d4b0deb500c

Device Description

Accessory connects micro-motors to the console or other boards, thus allowing the control and functioning of the whole device.

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
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
EBW Controller, foot, handpiece and cord

GMDN Terms

Code Name
37708 Remotely-driven surgical/dental system drive cable

Identifiers

Type ID
Primary J00716008810011

Customer Contacts