FDA.report

AURADONICS

Primary DI
00810033837005
Brand
AURADONICS
Company
AURADONICS INC.
Model
812-003 OSE
Device description
LATEX ELASTICS 3/16" 2.5 oz. - AMBER, 100 bags of 100, see www.auradonics.com
Published
2020-01-02
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
00810033837005PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00810033837005140081003383700508100338370050810033837005Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

TermDefinition
Orthodontic inter-arch elastic bandA non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. 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
true
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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