Rosidal

Primary DI
04021447969213
Brand
Rosidal
Company
Lohmann & Rauscher International GmbH & Co KG
Model
Sys
Catalog number
16984
Device description
Leg Ulcer Compression System for venous leg ulcer compression therapy.
Published
2023-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PYKVenous Ulcer Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYKVenous Ulcer KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04021447969213PackageGS14In Commercial Distribution
04021447969206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04021447969213040214479692134021447969213
04021447969206040214479692064021447969206

GMDN Terms#

Term, Definition table
TermDefinition
Compression bandaging kitA collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression layer (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home and healthcare facility. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
true
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
true
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04021447969206RosidalLohmann & Rauscher International GmbH & Co KGPYK2023-09-15
04042809400854Jobst®BSN medical GmbHPYK2022-12-08
04042809400878Jobst®BSN medical GmbHPYK2022-12-08
04042809400892Jobst®BSN medical GmbHPYK2022-12-08
04042809400915Jobst®BSN medical GmbHPYK2022-12-08
04042809400861Jobst®BSN medical GmbHPYK2022-12-08
04042809400885Jobst®BSN medical GmbHPYK2022-12-08
04042809400908Jobst®BSN medical GmbHPYK2022-12-08
04042809400922Jobst®BSN medical GmbHPYK2022-12-08