FDA.report

AURADONICS

Primary DI
00810033833182
Brand
AURADONICS
Company
AURADONICS INC.
Model
700-414 7.5
Device description
CHAIN LONG - LIGHT BLUE, 7.5 FT each, 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

Related Records

Product Codes

CodeName
ECIBand, Elastic, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810033833182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810033833182008100338331828100338331820810033833182

GMDN Terms

TermDefinition
Orthodontic inter-bracket elastic chainA non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Away from sunlight or strong light

Sterilization Methods

Method

Contacts

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 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

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