FDA UDI
In Commercial Distribution
🇺🇸 United States
Bariatric Table Extensions, Full Set of 8 with 2" Pads, 24" Leg Section
DI: 00810105030228
·
Model: 3-2001-001
·
COMPOSITE MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bariatric Table Extensions, Full Set of 8 with 2" Pads, 24" Leg Section
- Primary DI
- 00810105030228
- Version / Model
- 3-2001-001
- Catalog Number
- OZ 7557175
- Company Name
- COMPOSITE MANUFACTURING, INC.
- Labeler DUNS
- 947090650
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-14
- Public Version
- 1
- Public Version Date
- 2021-06-22
- Public Version Status
- New
- Public Device Record Key
- 2d70e2c8-4d3a-4d36-8950-a07ee1acaf90
Device Description
Modular, radiolucent carbon fiber surgical table width extenders for accommodating bariatric patients
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 |
|---|---|---|---|---|
| 65180 | Operating table patient positioning set, reusable | A collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810105030228 | GS1 |
Customer Contacts
- Phone
- 9493617580
- [email protected]