FDA UDI
In Commercial Distribution
🇺🇸 United States
MONTANE
DI: 05903684801909
·
Model: ALPS M-S5.F0 [SZER. 69] US
·
MEDEN INMED SP Z O O
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MONTANE
- Primary DI
- 05903684801909
- Version / Model
- ALPS M-S5.F0 [SZER. 69] US
- Catalog Number
- 3550
- Company Name
- MEDEN INMED SP Z O O
- Labeler DUNS
- 367142903
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-04
- Public Version
- 1
- Public Version Date
- 2022-11-14
- Public Version Status
- New
- Public Device Record Key
- e54f96e8-7707-4dfd-9edc-ed97726f89a4
Device Description
The MONTANE treatment table is a treatment table that facilitates manual therapies and massage treatment by enabling the patient to assume the proper position for treatment and to adjust the height and/or position each table section.
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
- 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 |
|---|---|---|---|---|
| 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 | 05903684801909 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 69 | Centimeter | |
| Length | 201 | Centimeter | |
| Height | 101 | Centimeter |