FDA UDI
In Commercial Distribution
🇺🇸 United States
Bariatric OR Table Set
DI: 04046768148499
·
Model: 100174F0
·
MAQUET GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Bariatric OR Table Set
- Primary DI
- 04046768148499
- Version / Model
- 100174F0
- Company Name
- MAQUET GmbH
- Labeler DUNS
- 315435859
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-03
- Public Version
- 1
- Public Version Date
- 2024-06-11
- Public Version Status
- New
- Public Device Record Key
- e26ac1b1-4196-4d3d-9a56-e31d9781cb96
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 |
|---|---|---|---|---|
| 65157 | Operating table mattress extension pad | A cushioned pad intended to increase the surface area of an operating table mattress upon which the patient is placed. It is attached to the operating table (e.g., table rails, patient restraint anchor) and is typically used to extend the mattress width to support a bariatric patient’s arms during a surgical procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046768148499 | GS1 |