FDA UDI
In Commercial Distribution
🇺🇸 United States
ARMDICA
DI: B866MAMSP4501
·
Model: AMSP450
·
ARMEDICA MANUFACTURING CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ARMDICA
- Primary DI
- B866MAMSP4501
- Version / Model
- AMSP450
- Catalog Number
- AMSP450
- Company Name
- ARMEDICA MANUFACTURING CORP.
- Labeler DUNS
- 018941711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-18
- Public Version
- 1
- Public Version Date
- 2022-11-28
- Public Version Status
- New
- Public Device Record Key
- e25c6601-832c-493d-a0a7-08816c09b654
Device Description
STEEL, ELECTRIC, PEDESTAL MOUNT, FOUR SECTION, 27 IN WIDE TREATMENT TABLE WITH ADJUSTABLE HEAD SECTION, ADJUSTABLE ARMRESTS, LUMBAR, ADJUSTABLE FOOT SECTION ON ROLLER TRACK, MACHINE STAND, 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 |
|---|---|---|---|---|---|---|
| Primary | B866MAMSP4501 | HIBCC | ||||
| Package | B866PAMSP4501 | HIBCC | SKID | 1 | In Commercial Distribution |