FDA.reportPublic FDA data

AURADONICS

Primary DI
00810033832130
Brand
AURADONICS
Company
AURADONICS INC.
Model
500-006
Device description
BULK SEPOS - SMALL 0.040", 1/8" O.D., WHITE, 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
OTC
false
Sterile
false
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
00810033832130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810033832130008100338321308100338321300810033832130

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8567648866auradonics@aol.com

Regulatory Flags#

DUNS number
608537379
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810033838446AURADONICS811-057NL2021-04-30
00810033838453AURADONICS811-060NL2021-04-30
00810033838460AURADONICS811-130NL2021-04-30
00810033838477AURADONICS811-164NNL2021-04-30
00810033838484AURADONICS811-229NNL2021-04-30
00810033838491AURADONICS811-232NNL2021-04-30
00810033838507AURADONICS811-233NNL2021-04-30
00810033838514AURADONICS811-234NNL2021-04-30
00810033838422AURADONICS811-062NL2020-12-22
00810033838439AURADONICS811-063NL2020-12-22
00810033834561AURADONICS811-0002020-01-02
00810033834578AURADONICS811-000NL2020-01-02
00810033834585AURADONICS811-0012020-01-02
00810033834592AURADONICS811-001NL2020-01-02
00810033834608AURADONICS811-0022020-01-02
00810033834615AURADONICS811-002NL2020-01-02
00810033834622AURADONICS811-0032020-01-02
00810033834639AURADONICS811-003NL2020-01-02
00810033834646AURADONICS811-0042020-01-02
00810033834653AURADONICS811-004NL2020-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00371347021028Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021035Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021042Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021059Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021066Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021073Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021080Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021097Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021103Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021110Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021127Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021134Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021141Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021158Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021165Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021172Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021189Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021196Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021202Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021219Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021226Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021233Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021240Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021257Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021264Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021271Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021288Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021295Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021301Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021318Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15