FDA.reportPublic FDA data

AURADONICS

Primary DI
00810033832123
Brand
AURADONICS
Company
AURADONICS INC.
Model
500-005
Device description
"BULK SEPOS - SMALL 0.040"", 1/8"" O.D., BLUE, 1000 devices per package, see www.auradonics.com"
Published
2019-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ECIBand, Elastic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810033832123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810033832123008100338321238100338321230810033832123

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic separatorA non-surgical orthodontic device typically in the form of a loop or ring intended to be placed between adjacent teeth to slowly move them apart to help achieve improved positioning and/or appearance of the teeth; it is not intended for separation of tooth roots. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Away from sunlight or strong light
Storage Environment Temperature6 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8567648866auradonics@aol.com

Regulatory Flags#

DUNS number
608537379
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810033830549AURADONICS300-215 GH2019-12-31
00810033831836AURADONICS300-7002019-12-31
00810033834295AURADONICS700-6182019-12-31
00810033834301AURADONICS700-6202019-12-31
00810033834318AURADONICS700-620T2019-12-31
00810033834325AURADONICS700-6252019-12-31
00810033834332AURADONICS700-625H2019-12-31
00810033834349AURADONICS700-625T2019-12-31
00810033834356AURADONICS700-6272019-12-31
00810033834363AURADONICS700-6302019-12-31
00810033834370AURADONICS700-630H2019-12-31
00810033834387AURADONICS700-630T2019-12-31
00810033834394AURADONICS700-6312019-12-31
00810033834400AURADONICS700-6452019-12-31
00810033834417AURADONICS700-7182019-12-31
00810033834424AURADONICS700-7202019-12-31
00810033834431AURADONICS700-720T2019-12-31
00810033834448AURADONICS700-7252019-12-31
00810033834455AURADONICS700-725H2019-12-31
00810033834462AURADONICS700-725T2019-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456205020JMUJMU DENTAL, INCECI2026-06-22
00840456205037JMUJMU DENTAL, INCECI2026-06-22
00840456205044JMUJMU DENTAL, INCECI2026-06-22
00840456205051JMUJMU DENTAL, INCECI2026-06-22
00840456205068JMUJMU DENTAL, INCECI2026-06-22
00840456205075JMUJMU DENTAL, INCECI2026-06-22
00840456205082JMUJMU DENTAL, INCECI2026-06-22
00840456205099JMUJMU DENTAL, INCECI2026-06-22
00840456205105JMUJMU DENTAL, INCECI2026-06-22
00840456205112JMUJMU DENTAL, INCECI2026-06-22
00840456205129JMUJMU DENTAL, INCECI2026-06-22
00840456205136JMUJMU DENTAL, INCECI2026-06-22
00840456205143JMUJMU DENTAL, INCECI2026-06-22
00840456205150JMUJMU DENTAL, INCECI2026-06-22
00840456205167JMUJMU DENTAL, INCECI2026-06-22
00840456205174JMUJMU DENTAL, INCECI2026-06-22
00840456205181JMUJMU DENTAL, INCECI2026-06-22
00840456205198JMUJMU DENTAL, INCECI2026-06-22
00840456205204JMUJMU DENTAL, INCECI2026-06-22
00840456205211JMUJMU DENTAL, INCECI2026-06-22
00840456205228JMUJMU DENTAL, INCECI2026-06-22
00840456205235JMUJMU DENTAL, INCECI2026-06-22
00840456205242JMUJMU DENTAL, INCECI2026-06-22
00840456205259JMUJMU DENTAL, INCECI2026-06-22
00840456205426JMUJMU DENTAL, INCECI2026-06-22
00840456205433JMUJMU DENTAL, INCECI2026-06-22
00840456205440JMUJMU DENTAL, INCECI2026-06-22
00840456205457JMUJMU DENTAL, INCECI2026-06-22
00840456205464JMUJMU DENTAL, INCECI2026-06-22
00840456205471JMUJMU DENTAL, INCECI2026-06-22