DryMax GENTLE F60056/10

GUDID 17350031912613

Superabsorbent dressing

Absorbest AB

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID17350031912613
NIH Device Record Key171cd6e7-e9de-4afe-ba10-aa1d2f4359a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDryMax GENTLE
Version Model NumberF60056/10
Catalog NumberF60056/10
Company DUNS631758273
Company NameAbsorbest AB
Device Count10
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter
Length20 Centimeter
Width20 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350031912616 [Primary]
GS117350031912613 [Unit of Use]

FDA Product Code

NACDressing, wound, hydrophilic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


[17350031912613]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-24
Device Publish Date2022-11-16

On-Brand Devices [DryMax GENTLE]

17350031912637Superabsorbent dressing
17350031912613Superabsorbent dressing
17350031912590Superabsorbent dressing
17350031912576Superabsorbent dressing

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.