FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GE Healthcare
DI: 00618125146147
·
Model: 32218
·
TIDI PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GE Healthcare
- Primary DI
- 00618125146147
- Version / Model
- 32218
- Company Name
- TIDI PRODUCTS, LLC
- Labeler DUNS
- 063519193
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-18
- Public Version
- 3
- Public Version Date
- 2023-03-02
- Public Version Status
- Update
- Public Device Record Key
- d0ffb2d8-7339-4321-a8c1-1fceb47d659b
- Distribution End Date
- 2023-03-01
Device Description
WEDGE, AXIAL HEADHOLDER, 10°
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
- 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
- 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 |
|---|---|---|---|---|
| IWY | Holder, Head, Radiographic | Radiology | 892.1920 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00618125146147 | GS1 |