FDA.report

AURADONICS

Primary DI
00810033835889
Brand
AURADONICS
Company
AURADONICS INC.
Model
811-159NL
Device description
LATEX-FREE ELASTICS 3/8" 3.5 oz - CLEAR, 50 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
00810033835889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810033835889008100338358898100338358890810033835889

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
Storage Environment Temperature6 Degrees Celsius25 Degrees Celsius

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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