FDA UDI
In Commercial Distribution
🇺🇸 United States
ATMOS
DI: 04250365166187
·
Model: S 61 Servant Vision
·
ATMOS MedizinTechnik GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ATMOS
- Primary DI
- 04250365166187
- Version / Model
- S 61 Servant Vision
- Company Name
- ATMOS MedizinTechnik GmbH & Co. KG
- Labeler DUNS
- 319591939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-27
- Public Version
- 1
- Public Version Date
- 2024-12-05
- Public Version Status
- New
- Public Device Record Key
- 2e52abdc-99aa-4e2f-a12b-0e123c105045
Device Description
The device is intended to illuminate natural orifices (e.g. ear/nose/throat) for visual diagnosis, for storage and management endoscopes, diagnostic devices or visualisation devices for ENT specialists. The user can assemble the workplace with options and accessories according to his personal requirements. The device is used in clinics or ENT offices.
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
- 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 |
|---|---|---|---|---|
| ETF | Unit, Examining/Treatment, Ent | Ear, Nose, Throat | 874.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44380 | ENT cabinet | A stand-alone, furniture-like device designed to store, display, and provide readily accessible for the operator the instruments, devices, and materials, including the local anaesthetics used in ear/nose/throat (ENT) treatments/procedures. This device is used in hospitals and physician's offices and will typically have a worktop intended to facilitate the intervention. The device may include features, e.g., suction and pressure pumps, fibreoptic-light source, built-in electrical outlets. It will have wheels for easy movement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250365166187 | GS1 |