FDA.reportPublic FDA data

DryMax GENTLE

Primary DI
07350031912630
Brand
DryMax GENTLE
Company
Absorbest AB
Model
F60057/10
Catalog number
F60057/10
Device description
Superabsorbent dressing
Published
2022-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, wound, hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350031912630PrimaryGS10
17350031912637Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350031912630073500319126307350031912630
1735003191263717350031912637

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter
Width20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
631758273
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350031914009DryMax SoftF60125/10F60125/102024-11-26
17350031914006DryMax SoftF60125/10F60125/102024-11-26
07350031913934Absorbest Super FoamF60041/10F60041/102024-07-12
07350031913941Absorbest Super FoamF60043/10F60043/102024-07-12
07350031913958Absorbest Super FoamF60044/10F60044/102024-07-12
07350031913965Absorbest Super FoamF60045/10F60045/102024-07-12
07350031913972Absorbest Super FoamF60046/10F60046/102024-07-12
17350031913931Absorbest Super FoamF60041/10F60041/102024-07-12
17350031913948Absorbest Super FoamF60043/10F60043/102024-07-12
17350031913955Absorbest Super FoamF60044/10F60044/102024-07-12
17350031913962Absorbest Super FoamF60045/10F60045/102024-07-12
17350031913979Absorbest Super FoamF60046/10F60046/102024-07-12
07350031913903DryMax SOFTF60123/10F60123/102024-04-17
07350031912050DryMax SOFTF60013/10F60013/102022-11-16
07350031912111DryMax SOFTF60015/10F60015/102022-11-16
07350031912142DryMax BORDERF50513/10F50513/102022-11-16
07350031912173DryMax SOFTF60016/10F60016/102022-11-16
07350031912234DryMax SOFTF60017/10F60017/102022-11-16
07350031912265DryMax SOFTF60019/10F60019/102022-11-16
07350031912296DryMax FOAMF60041/10F60041/102022-11-16

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