FDA UDI
In Commercial Distribution
🇺🇸 United States
HCS
DI: 00810132040795
·
Model: HCS0207
·
Concordance Healthcare Solutions LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- HCS
- Primary DI
- 00810132040795
- Version / Model
- HCS0207
- Company Name
- Concordance Healthcare Solutions LLC
- Labeler DUNS
- 080220245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-05-01
- Public Version
- 2
- Public Version Date
- 2025-11-18
- Public Version Status
- Update
- Public Device Record Key
- 59cb9b8f-b15f-4d81-9983-c80732b18d72
Device Description
2.5" x 3", Alcohol Prep Pad, Large, 2 Ply, Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10810132040792 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00810132040795 | GS1 | ||||
| Unit of Use | 20810132040799 | GS1 |