FDA UDI In Commercial Distribution 🇺🇸 United States

AURADONICS

DI: 00810033834370 · Model: 700-630H · AURADONICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AURADONICS
Primary DI
00810033834370
Version / Model
700-630H
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
61f96a62-ef94-464d-82d0-771bfd91b695

Device Description

TUBING .030 OD CLEAR SMOOTH - 25 FT, 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 00810033834370

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