FDA UDI
In Commercial Distribution
🇺🇸 United States
Schaerer Medical
DI: 07640143933044
·
Model: 91451
·
Schaerer Medical AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Schaerer Medical
- Primary DI
- 07640143933044
- Version / Model
- 91451
- Catalog Number
- 91451
- Company Name
- Schaerer Medical AG
- Labeler DUNS
- 484713792
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-03
- Public Version
- 2
- Public Version Date
- 2025-03-18
- Public Version Status
- Update
- Public Device Record Key
- f98091f1-077c-45b8-a58b-94a242c57f51
Device Description
Head rest standard axis 7300
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58055 | Operating/examination/treatment table headrest, reusable | A device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. It is available in various shapes and sizes and might include mechanisms to enable adjustments in relation to the table top. It does not include components intended for immobilization of the head (i.e., not a positioner). This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640143933044 | GS1 |