FDA UDI
In Commercial Distribution
🇺🇸 United States
Custom Healthcare Systems Inc.
DI: 00811870031038
·
Model: R1186 / 12880
·
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
- 00811870031038
- Version / Model
- R1186 / 12880
- Company Name
- Manus Medical, LLC
- Labeler DUNS
- 800604196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-29
- Public Version
- 3
- Public Version Date
- 2023-06-08
- Public Version Status
- Update
- Public Device Record Key
- 8154bbd2-07d3-4c79-b6f0-35d7d783381d
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
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KJG | Tube, Tissue Culture | Pathology | 864.3010 | 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 | 20811870031032 | GS1 | N/A | 50 | In Commercial Distribution | |
| Primary | 00811870031038 | GS1 |