FDA UDI
In Commercial Distribution
🇺🇸 United States
Leukomed® Sorbact®
DI: 07392130003543
·
Model: 76199-37
·
BSN medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
20
Basic Information
- Brand Name
- Leukomed® Sorbact®
- Primary DI
- 07392130003543
- Version / Model
- 76199-37
- Catalog Number
- 76199-37
- Company Name
- BSN medical GmbH
- Labeler DUNS
- 342651662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-01-26
- Public Version
- 1
- Public Version Date
- 2024-02-05
- Public Version Status
- New
- Public Device Record Key
- 92142281-0567-4841-b95c-4c6badb02b3a
Device Description
LEUKOMED SORBACT STERILE 8CMX15CM 20 US HOSP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58741 | Microbe-binding hydrophobic dressing | A sterile wound covering intended to remove microorganisms (bacteria, fungi) from a wound site through hydrophobic binding, and subsequent dressing removal/exchange. It is a fabric material (e.g., cellulose acetate, cotton) available in various forms, with a strongly hydrophobic surface (e.g., covered by a fatty acid ester). It is intended to be applied to a variety of clean, contaminated, colonized or infected wounds (e.g., trauma wounds, surgical wounds, diabetic ulcers, pressure ulcers, burns) to reduce the levels of microorganisms and promote wound healing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07392130003611 | GS1 | shipping case | 10 | In Commercial Distribution | |
| Primary | 07392130003543 | GS1 | ||||
| Unit of Use | 07392130003475 | GS1 | ||||
| Previous | 04042809657548 | GS1 |
Customer Contacts
- Phone
- +1(800)537-1063
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15 | Centimeter | |
| Width | 8 | Centimeter |