FDA UDI
In Commercial Distribution
🇺🇸 United States
ALLEN
DI: 00615521003012
·
Model: 107003
·
ALLEN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ALLEN
- Primary DI
- 00615521003012
- Version / Model
- 107003
- Catalog Number
- A-71100-US
- Company Name
- ALLEN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 147805894
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-26
- Public Version
- 1
- Public Version Date
- 2023-06-05
- Public Version Status
- New
- Public Device Record Key
- 9961950b-3194-4abf-97d3-363fc9d37bd6
Device Description
Allen Advance Table
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46083 | Traction table, line-powered | A mobile, mains electricity (AC-powered) table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine. The table surface may consist of sections that can be raised and lowered to manipulate the curvature of the patient?s spine, or apply a rotational roller mechanism protruding through the table surface to the spine, or employ masts and traction accessories for lumbar and cervical traction in a sitting position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is used in a healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00615521003012 | GS1 |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]