FDA UDI
In Commercial Distribution
🇺🇸 United States
CUSTOM HEALTHCARE SYSTEMS, INC
DI: 00811870034053
·
Model: D40-11262
·
Manus Medical, LLC
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CUSTOM HEALTHCARE SYSTEMS, INC
- Primary DI
- 00811870034053
- Version / Model
- D40-11262
- Company Name
- Manus Medical, LLC
- Labeler DUNS
- 800604196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-04
- Public Version
- 3
- Public Version Date
- 2023-06-08
- Public Version Status
- Update
- Public Device Record Key
- 430a0bca-97cc-401b-ac04-786a126ee45c
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
- No
- 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 |
|---|---|---|---|---|
| LRO | General Surgery Tray | General, Plastic Surgery | 878.4370 | 2 |
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 |
| 37942 | Palate prosthesis | An artificial substitute for the hard palate used to reproduce the function of the palate typically in cases of a palatal cleft or fistula, or for palatal augmentation. It will help to improve the patient's speech and eating ability by occluding the defective opening, and in some cases by improving the positioning of their tongue and improving swallowing. Teeth are usually mounted on the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20811870034057 | GS1 | N/A | 50 | In Commercial Distribution | |
| Primary | 00811870034053 | GS1 |