Primary Device ID | ERKO5893253 |
NIH Device Record Key | 016a9e52-1d8d-4bee-81cb-d2a1d14d5118 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Erkoflex-95 |
Version Model Number | 589325 |
Company DUNS | 317654200 |
Company Name | Erkodent Erich Kopp GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | ERKO5893253 [Primary] |
MQC | Mouthguard, Prescription |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-02 |
Device Publish Date | 2021-08-25 |
ERKO5893403 | Erkoflex-95, 4.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o |
ERKO5893253 | Erkoflex-95, 2.50 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o |
ERKO5893153 | Erkoflex-95, 1.50 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o |
ERKO5892251 | Erkoflex-95, 2.50 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o |
ERKO5859251 | Erkoflex-95, 2.50 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication o |
ERKO5854152 | Erkoflex-95, 1.50 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication o |