FDA UDI
In Commercial Distribution
🇺🇸 United States
Debrisoft
DI: 04056649025665
·
Model: Lolly
·
Lohmann & Rauscher International GmbH & Co KG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Debrisoft
- Primary DI
- 04056649025665
- Version / Model
- Lolly
- Catalog Number
- 33224
- 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
- 2023-06-07
- Public Version
- 1
- Public Version Date
- 2023-06-15
- Public Version Status
- New
- Public Device Record Key
- 730bfea7-78fe-46d1-a78c-ab07821f0933
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | 878.4450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58294 | Wound debridement pad | A sterile device intended to be used for the manual debridement of wounds (e.g., diabetic foot ulcers, venous ulcers, arterial ulcers, pressure ulcers, bedsores) by gentle wiping of the wound surface to remove unhealthy tissue (e.g., exudate, slough, cellular debris) to promote healing. It typically consists of a swab-like pad with the side to be used for debridement made of synthetic polymer (e.g., monofilament polyester) fibres. It may be soaked in water/saline before use. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04021447849829 | GS1 | shelf container | 5 | In Commercial Distribution | |
| Primary | 04056649025665 | GS1 | ||||
| Package | 04021447849836 | GS1 | transit container | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight