DryMax BORDER F50511/10

GUDID 17350031912361

Superabsorbent dressing

Absorbest AB

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID17350031912361
NIH Device Record Keyd8527da9-903e-485d-b25c-ed2d4c3e18f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDryMax BORDER
Version Model NumberF50511/10
Catalog NumberF50511/10
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

Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter
Length7.5 Centimeter
Width7.5 Centimeter

Operating and Storage Conditions

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 *Avoid direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS107350031912364 [Primary]
GS117350031912361 [Unit of Use]

FDA Product Code

NACDressing, wound, hydrophilic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


[17350031912361]

Ethylene Oxide


Device Entry Metadata

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

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