FDA UDI In Commercial Distribution 🇺🇸 United States

PHOENIX

DI: 00810033837623 · Model: P-300-203 · AURADONICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PHOENIX
Primary DI
00810033837623
Version / Model
P-300-203
Company Name
AURADONICS INC.
Labeler DUNS
608537379
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-12-31
Public Version
2
Public Version Date
2021-06-22
Public Version Status
Update
Public Device Record Key
a3482d9e-d660-4fe8-a782-26aa7001ea47

Device Description

KEYTIES - NEON GREEN, 1000 devices per package, see www.auradonics.com

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
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ECI Band, Elastic, Orthodontic

GMDN Terms

Code Name
41677 Orthodontic archwire/bracket ligature

Identifiers

Type ID
Primary 00810033837623

Customer Contacts

Phone
8567648866

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
6 – 25 Degrees Celsius
Type
Special Storage Condition, Specify
Special Conditions
Away from sunlight or strong light