FDA UDI
In Commercial Distribution
🇺🇸 United States
Rosidal
DI: 04021447969206
·
Model: Sys
·
Lohmann & Rauscher International GmbH & Co KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Rosidal
- Primary DI
- 04021447969206
- Version / Model
- Sys
- Catalog Number
- 16984
- Company Name
- Lohmann & Rauscher International GmbH & Co KG
- Labeler DUNS
- 315505235
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-15
- Public Version
- 1
- Public Version Date
- 2023-09-25
- Public Version Status
- New
- Public Device Record Key
- e7dfa92a-d0db-48f7-bd9f-ee50119e2176
Device Description
Leg Ulcer Compression System for venous leg ulcer compression therapy.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PYK | Venous Ulcer Kit | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58983 | Compression bandaging kit | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04021447969213 | GS1 | TC | 4 | In Commercial Distribution | |
| Primary | 04021447969206 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep away from sunlight