FDA UDI
In Commercial Distribution
🇺🇸 United States
Adapter for RADIOLUCENT SPINE SURGERY FRAME
DI: 04046768113718
·
Model: 100730A0
·
MAQUET GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Adapter for RADIOLUCENT SPINE SURGERY FRAME
- Primary DI
- 04046768113718
- Version / Model
- 100730A0
- Company Name
- MAQUET GmbH
- Labeler DUNS
- 315435859
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-22
- Public Version
- 1
- Public Version Date
- 2022-09-30
- Public Version Status
- New
- Public Device Record Key
- 6ad601d3-1f3d-43e2-b737-39e5750d090a
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 |
|---|---|---|---|---|
| BWN | TABLE AND ATTACHMENTS, OPERATING-ROOM | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46208 | Spinal surgery positioning board | A device comprised of a supportive foundation and adjustable positioning elements designed to be attached to an operating table to enable correct positioning and immobilization of a patient during surgical procedures involving the spine (e.g., thoracolumbrosacral surgery, disc decompression). It supports the patient in the prone or supine position providing a close approximation to a patient's natural lumbar lordosis while facilitating reduced abdominal compression. It typically consists of a base plate/board made of durable materials (e.g., metal, carbon fibre) to which other devices are attached (e.g., intraoperative positioners, headrest, x-ray cassette). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046768113718 | GS1 |