FDA UDI
In Commercial Distribution
🇺🇸 United States
MONTANE
DI: 05903684802319
·
Model: ANDES M-P7.F4 [SZER 76 CM]
·
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
- 05903684802319
- Version / Model
- ANDES M-P7.F4 [SZER 76 CM]
- Catalog Number
- 3573XL
- 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
- 2023-09-25
- Public Version
- 1
- Public Version Date
- 2023-10-03
- Public Version Status
- New
- Public Device Record Key
- 908cd97c-fc87-434b-bc37-235c2796f731
Device Description
The TERAPEUTA massage table is designed to be used in administration of the manual therapy techniques and physiotherapy to heal or provide relief in injuries or other impairments by restoring or improving the functions of the tissues, organs and systems.
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 |
|---|---|---|---|---|
| 34852 | Massage table/couch, non-powered, portable | A manually-adjusted, portable table designed for various kinds of complementary therapy (e.g., massage, acupuncture, aromatherapy, reflexology, kinesiology). It consists of a foldable framework (table top and legs) with a flat tabletop surface which may have a head section that can be manually adjusted. The height of the table may also be manually adjusted to fixed positions (i.e., set to an initial height but not readily adjustable). It may incorporate a face hole (the patients face fits into this when lying prone), a headrest, and an armrest(s). This device is typically known as a massage/therapy table, couch or bed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05903684802319 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 201 | Centimeter | |
| Height | 101 | Centimeter | |
| Width | 76 | Centimeter |