FDA UDI
In Commercial Distribution
🇺🇸 United States
Head-Positioning accessories
DI: 00887761972889
·
Model: 1345749
·
Baxter Medical Systems GmbH + Co. KG
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Head-Positioning accessories
- Primary DI
- 00887761972889
- Version / Model
- 1345749
- Company Name
- Baxter Medical Systems GmbH + Co. KG
- Labeler DUNS
- 330961223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-05
- Public Version
- 3
- Public Version Date
- 2023-02-09
- Public Version Status
- Update
- Public Device Record Key
- 69d37df7-7fcc-4641-aa12-03c6f40c5cea
Device Description
Retainer X-RAY
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 |
|---|---|---|---|---|
| FQP | Lamp, operating-room | General, Plastic Surgery | 878.4580 | 2 |
| FSQ | Light, surgical, instrument | General, Plastic Surgery | 878.4580 | 2 |
| FTD | Lamp, surgical | General, Plastic Surgery | 878.4580 | 2 |
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. This is a general-purpose headrest available in various shapes and sizes and might include mechanical mechanisms to enable adjustments in relation to the table top. 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 | 00887761972889 | GS1 |
Customer Contacts
- Phone
- +4936715860
- [email protected]