FDA UDI
In Commercial Distribution
🇺🇸 United States
LEADER
DI: 00096295125542
·
Model: 4935474
·
Cardinal Health 110, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
8
Basic Information
- Brand Name
- LEADER
- Primary DI
- 00096295125542
- Version / Model
- 4935474
- Catalog Number
- 4935474
- Company Name
- Cardinal Health 110, Inc.
- Labeler DUNS
- 063997360
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2019-04-18
- Public Version
- 3
- Public Version Date
- 2021-07-02
- Public Version Status
- Update
- Public Device Record Key
- a55953f0-cf4c-41ff-8495-efaa5437964c
Device Description
Advanced Antibacterial Fabric Bandages; First Aid Antiseptic; Helps Prevent Infections; Pain Free Film; Kills Bacteria; 3X Absorbent Pad; Active Ingredient Benzalkonium Chloride 0.1%; All One Size 3/4 IN. x 3 IN.
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape and bandage, adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47378 | Skin-cover adhesive strip, antimicrobial | A small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50096295125547 | GS1 | CASE | 72 | In Commercial Distribution | |
| Primary | 00096295125542 | GS1 | ||||
| Unit of Use | 10096295125549 | GS1 |
Customer Contacts
- Phone
- +1(800)200-6313
- [email protected]