FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10810050245453
·
Model: 303-UF
·
DOMICO MED-DEVICE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- NA
- Primary DI
- 10810050245453
- Version / Model
- 303-UF
- Company Name
- DOMICO MED-DEVICE, LLC
- Labeler DUNS
- 081253414
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-11-18
- Public Version
- 1
- Public Version Date
- 2022-11-28
- Public Version Status
- New
- Public Device Record Key
- 99359772-9262-414c-8100-184f867b5d81
Device Description
HEAD-ENDS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41058 | Multifunction body cushion | A soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810050245456 | GS1 | ||||
| Primary | 10810050245453 | GS1 |