FDA.reportPublic FDA data

DryMax BORDER

Primary DI
07350031912142
Brand
DryMax BORDER
Company
Absorbest AB
Model
F50513/10
Catalog number
F50513/10
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
07350031912142PrimaryGS10
17350031912149Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350031912142073500319121427350031912142
1735003191214917350031912149

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
Length10Centimeter
Width10Centimeter

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
07350031912173DryMax SOFTF60016/10F60016/102022-11-16
07350031912234DryMax SOFTF60017/10F60017/102022-11-16
07350031912265DryMax SOFTF60019/10F60019/102022-11-16
07350031912296DryMax FOAMF60041/10F60041/102022-11-16
07350031912388DryMax BORDERF50514/10F50514/102022-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01714196634404HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196635500HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196637702HydraLock SA with BorderSion Brands LLCNAC2026-07-16
10197344175963MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175970MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175987MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
00850088144314CARBOUNingbo kehu Medical Technology Co.,Ltd.NAC2026-07-08
00197344111513CURADMEDLINE INDUSTRIES, INC.NAC2026-07-03
00197998001727Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295812Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295850Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295898Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295942Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940052DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940069DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940076DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940083DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940090DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940106DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22