FDA UDI
In Commercial Distribution
🇺🇸 United States
Head-Positioning accessories
DI: 00887761972797
·
Model: 1537214
·
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
- 00887761972797
- Version / Model
- 1537214
- 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
- 2022-12-27
- Public Version
- 2
- Public Version Date
- 2023-02-09
- Public Version Status
- Update
- Public Device Record Key
- e61c6b8a-829c-4c9f-ad79-51d209b69397
Device Description
Head Rest horseshoe-shaped COMFORT
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 |
|---|---|---|---|---|
| GDC | TABLE, OPERATING-ROOM, ELECTRICAL | General, Plastic Surgery | 878.4960 | 1 |
| JEA | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED | General, Plastic Surgery | 878.4960 | 1 |
| KXJ | Table, radiologic | Radiology | 892.1980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42308 | Operating table orthopaedic extension | An orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder or spinal surgery, C- or O-arm use). It typically consists of height, length and angle adjustable supports or telescopic bars/plates. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887761972797 | GS1 |
Customer Contacts
- Phone
- +4936715860
- [email protected]