FDA UDI
In Commercial Distribution
🇺🇸 United States
Debrisoft
DI: 04068225274879
·
Model: Duo 10x10cm
·
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
- 04068225274879
- Version / Model
- Duo 10x10cm
- Catalog Number
- 31222
- 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
- 2024-10-16
- Public Version
- 2
- Public Version Date
- 2026-01-12
- Public Version Status
- Update
- Public Device Record Key
- 73274baa-bc2e-4430-a400-e7a270831984
Device Description
L&R no. 159993
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 |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58294 | Manual wound debridement tool | A 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 is available in a variety of forms (e.g., a swab-like pad with a handle, a thimble-like device worn on the end of a finger); the surface used for debridement is typically made of synthetic polymer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04068225274886 | GS1 | SC | 5 | In Commercial Distribution | |
| Primary | 04068225274879 | GS1 | ||||
| Package | 04068225274893 | GS1 | TC | 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