FDA UDI
In Commercial Distribution
🇺🇸 United States
Kerlix
DI: 20192253046974
·
Model: 6660
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- Kerlix
- Primary DI
- 20192253046974
- Version / Model
- 6660
- Catalog Number
- 6660
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-09-24
- Public Version
- 1
- Public Version Date
- 2025-10-02
- Public Version Status
- New
- Public Device Record Key
- e26af943-c9af-4bca-abde-eebaa5f034b3
Device Description
Kerlix AMD Antimicrobial Super Sponges Medium • 0.2% Polyhexamethylene Biguanide HCl (PHMB) 6 in. x 6.75 in. (15.2 cm x 17.1 cm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| NAD | Dressing, wound, occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48129 | Gauze strip, antimicrobial | A thin length of woven material (e.g., cotton, cellulose) that is impregnated with an antimicrobial agent (e.g., iodoform) and primarily designed to pack draining wounds to absorb exudates. It may be soaked with other medication (not included) before application. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253046975 | GS1 | CASE | 48 | In Commercial Distribution | |
| Primary | 20192253046974 | GS1 | ||||
| Unit of Use | 10192253046977 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 15.2 | Centimeter | |
| Length | 17.1 | Centimeter |