FDA.reportPublic FDA data

Vliwasorb

Primary DI
04056649067511
Brand
Vliwasorb
Company
Lohmann & Rauscher International GmbH & Co KG
Model
Pro 22x32cm
Catalog number
32644
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
04056649067511PackageGS110In Commercial Distribution
04056649067566PackageGS19In Commercial Distribution
04056649067504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056649067511040566490675114056649067511
04056649067566040566490675664056649067566
04056649067504040566490675044056649067504

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not resterilize
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00keep away from sunlight
Special Storage Condition, Specify00keep dry

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315505235
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04068225066993SuprasorbF Protect 10 cm x 12 cm1624622024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09551031940113DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940120DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940137DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940144DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940151DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940168DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940175DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940182DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940199DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940205DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940212DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940229DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940243DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940250DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940267DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940274DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940281DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940298DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22