FDA UDI
In Commercial Distribution
🇺🇸 United States
CUSTOM HEALTHCARE SYSTEMS, INC
DI: 00811870033162
·
Model: YMCP-TCRS02
·
Manus Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CUSTOM HEALTHCARE SYSTEMS, INC
- Primary DI
- 00811870033162
- Version / Model
- YMCP-TCRS02
- Company Name
- Manus Medical, LLC
- Labeler DUNS
- 800604196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-22
- Public Version
- 3
- Public Version Date
- 2023-06-08
- Public Version Status
- Update
- Public Device Record Key
- aaae3e76-912a-465c-bd76-50fd25dd72a5
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35246 | Surgical patient preparation kit | A collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20811870033166 | GS1 | N/A | 6 | In Commercial Distribution | |
| Primary | 00811870033162 | GS1 |