D42 dermatome set 4.D42STS

GUDID 08717903490402

Humeca B.V.

Dermatome handpiece, electrically-powered

Primary Device ID	08717903490402
NIH Device Record Key	3fb62665-9b44-4245-9c1d-7be49d3992cc
Commercial Distribution Status	In Commercial Distribution
Brand Name	D42 dermatome set
Version Model Number	4.D42STS
Catalog Number	4.D42STS
Company DUNS	489831498
Company Name	Humeca B.V.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717903490358 [Primary]
GS1	08717903490402 [Direct Marking]

FDA Product Code

GFD

Dermatome