FDA UDI
In Commercial Distribution
🇺🇸 United States
Dukal
DI: 50665973025075
·
Model: 857-4000-X
·
Dukal LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4000
Basic Information
- Brand Name
- Dukal
- Primary DI
- 50665973025075
- Version / Model
- 857-4000-X
- Catalog Number
- 857-4000-X
- Company Name
- Dukal LLC
- Labeler DUNS
- 791014871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4000
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 1
- Public Version Date
- 2022-12-14
- Public Version Status
- New
- Public Device Record Key
- 5b152731-9107-4d5e-a3ac-62f2db00158a
Device Description
Alcohol Prep Pad, Medium, Sterile
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
- 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 |
|---|---|---|---|---|
| LKB | Pad, alcohol, device disinfectant | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58077 | Medical device cleaning/disinfection wipe | A moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00665973025070 | GS1 | ||||
| Primary | 50665973025075 | GS1 |
Customer Contacts
- Phone
- +1(631)656-3800 ext. 172
- [email protected]