FDA.reportPublic FDA data

Suprasorb

Primary DI
04021447013169
Brand
Suprasorb
Company
Lohmann & Rauscher International GmbH & Co KG
Model
P non adhesive
Catalog number
20407
Published
2022-11-17
Public version status
New
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
04021447013176PackageGS110In Commercial Distribution
04021447204079PackageGS110In Commercial Distribution
04021447013169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04021447013176040214470131764021447013176
04021447204079040214472040794021447204079
04021447013169040214470131694021447013169

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep away from sunlight
Special Storage Condition, Specify00keep dry
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
315505235
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04021447165158Pro-ophta@Ocular Sticks165152016-10-17
04021447537771DebrisoftPad 10x10cm312222022-11-17
04056649025665DebrisoftLolly332242023-06-07
04056649070344DebrisoftPad 10x10cm343212022-11-17
04056649070429DebrisoftPad 13x20cm343232022-11-17
04068225259449DebrisoftDuo 10x10cm1599902024-10-16
04068225259463DebrisoftDuo 13x20cm1599912024-10-16
04068225269608DebrisoftDuo 10x10cm1599922024-10-16
04068225274879DebrisoftDuo 10x10cm312222024-10-16
04021447206028VaricexZinc Paste Bandage206022022-11-17
04021447206325VaricexZinc Paste Bandage206322022-11-17
04068225066924SuprasorbF Protect 5 x 7 cm1624602024-11-15
04068225066955SuprasorbF Protect 5 x 7 cm1624612024-11-15
04068225066986SuprasorbF Protect 10 cm x 12 cm1624622024-11-15
04068225067013SuprasorbF Protect 10 cm x 12 cm1624632024-11-15
04068225067044SuprasorbF Protect 10 cm x 25 cm1624642024-11-15
04068225067075SuprasorbF Protect 15 cm x 20 cm1624652024-11-15
04068225067105SuprasorbF Protect 20 x 30 cm1624662024-11-15
04068225066931SuprasorbF Protect 5 x 7 cm1624602024-11-15
04068225066962SuprasorbF Protect 5 x 7 cm1624612024-11-15

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