FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SMR MAXI CABINET, STAINLESS STEEL, DELUXE, NO OTOSCOPES, 220-240V, REQUIRES S 74
DI: 00810040252495
·
Model: S 168070D-230
·
GLOBAL SURGICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SMR MAXI CABINET, STAINLESS STEEL, DELUXE, NO OTOSCOPES, 220-240V, REQUIRES S 74
- Primary DI
- 00810040252495
- Version / Model
- S 168070D-230
- Company Name
- GLOBAL SURGICAL CORPORATION
- Labeler DUNS
- 824793335
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-20
- Public Version
- 2
- Public Version Date
- 2024-01-12
- Public Version Status
- Update
- Public Device Record Key
- 0b595a8e-b8ac-4ae6-a2a1-0ad63400ea56
- Distribution End Date
- 2023-12-31
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 | 00810040252495 | GS1 |