FDA UDI
In Commercial Distribution
🇺🇸 United States
ARMEDICA
DI: B866MAMTM5001
·
Model: AMTM500
·
ARMEDICA MANUFACTURING CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ARMEDICA
- Primary DI
- B866MAMTM5001
- Version / Model
- AMTM500
- Catalog Number
- AMTM500
- Company Name
- ARMEDICA MANUFACTURING CORP.
- Labeler DUNS
- 018941711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-06
- Public Version
- 1
- Public Version Date
- 2024-12-16
- Public Version Status
- New
- Public Device Record Key
- 692d3fa1-9a88-4042-b2f2-f583d2970474
Device Description
Steel, electrical, three section treatment table, 27 inches wide, adjustable 3 piece head section, adjustable center and foot section, and casters
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| INQ | Table, Powered | Physical Medicine | 890.3760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31362 | Examination/treatment table, line-powered | A mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B866PAMTM5001 | HIBCC | PALLET | 1 | In Commercial Distribution | |
| Primary | B866MAMTM5001 | HIBCC |