Erkodur freeze

GUDID ERKO5291301

Erkodur freeze, 3.00 mm, Ø 120 mm, turquoise. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Erkodent Erich Kopp GmbH

Dental appliance fabrication material, thermoplastic
Primary Device IDERKO5291301
NIH Device Record Key66dbc62f-560b-4c03-ba9e-623d79d95afa
Commercial Distribution StatusIn Commercial Distribution
Brand NameErkodur freeze
Version Model Number529130
Company DUNS317654200
Company NameErkodent Erich Kopp GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCERKO5291301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQCMouthguard, Prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-29
Device Publish Date2021-09-21

On-Brand Devices [Erkodur freeze]

ERKO5294302Erkodur freeze, 3.00 mm, Ø 120 mm, turquoise. Thermoforming sheet material for the fabrication
ERKO5294202Erkodur freeze, 2.00 mm, Ø 120 mm, turquoise. Thermoforming sheet material for the fabrication
ERKO5291301Erkodur freeze, 3.00 mm, Ø 120 mm, turquoise. Thermoforming sheet material for the fabrication
ERKO5291251Erkodur freeze, 2.50 mm, Ø 120 mm, turquoise. Thermoforming sheet material for the fabrication
ERKO5291201Erkodur freeze, 2.00 mm, Ø 120 mm, turquoise. Thermoforming sheet material for the fabrication
ERKO5291101Erkodur freeze, 1.00 mm, Ø 120 mm, turquoise. Thermoforming sheet material for the fabrication
ERKO5275201Erkodur freeze, 2.00 mm, Ø 125 mm, turquoise. Thermoforming sheet material for the fabrication

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