FDA UDI
In Commercial Distribution
🇺🇸 United States
Leukomed®
DI: 04042809525571
·
Model: 73230-00
·
BSN medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Leukomed®
- Primary DI
- 04042809525571
- Version / Model
- 73230-00
- Catalog Number
- 73230-00
- Company Name
- BSN medical GmbH
- Labeler DUNS
- 342651662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 3
- Public Version Date
- 2023-10-12
- Public Version Status
- Update
- Public Device Record Key
- e7746122-6d6c-4a92-b5a0-2d8e62bae298
Device Description
LEUKOMED CONTROL STERILE 5X7CM 10
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NAE | Dressing, wound, hydrogel without drug and/or biologic | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04042809525588 | GS1 | 28 | In Commercial Distribution | ||
| Primary | 04042809525571 | GS1 | ||||
| Unit of Use | 04042809525984 | GS1 |
Customer Contacts
- Phone
- +1(800)537-1063
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7 | Centimeter | |
| Width | 5 | Centimeter |