FDA UDI
In Commercial Distribution
🇺🇸 United States
Soule Medical
DI: 00810082222357
·
Model: CF1007DH
·
SOULE CO., THE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Soule Medical
- Primary DI
- 00810082222357
- Version / Model
- CF1007DH
- Catalog Number
- CF1007DH
- Company Name
- SOULE CO., THE
- Labeler DUNS
- 032801706
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-14
- Public Version
- 1
- Public Version Date
- 2022-09-22
- Public Version Status
- New
- Public Device Record Key
- c7c18420-aec1-4f22-b3a9-5bef236c9949
Device Description
7" Height Prone Headrest. With Comfort Foam and Dual Sided Intubation Slot
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 64413 | Freestanding headrest, single-use | A device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position the head. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810082223934 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00810082222357 | GS1 |