FDA.report

AURADONICS

Primary DI
00810033834523
Brand
AURADONICS
Company
AURADONICS INC.
Model
700-745
Device description
LIP BUMPER .045 ID GRAY SMOOTH - 10 FT, see www.auradonics.com
Published
2019-12-31
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
00810033834523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810033834523008100338345238100338345230810033834523

GMDN Terms

TermDefinition
Orthodontic archwire/bracket ligatureA device intended to hold an orthodontic archwire securely in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie or circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. 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
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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