FDA UDI
In Commercial Distribution
🇺🇸 United States
INTENSA
DI: M368744T2SBCSW1
·
Model: 744-T2-SBCSW
·
GF HEALTH PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- INTENSA
- Primary DI
- M368744T2SBCSW1
- Version / Model
- 744-T2-SBCSW
- Company Name
- GF HEALTH PRODUCTS, INC.
- Labeler DUNS
- 132016168
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-15
- Public Version
- 3
- Public Version Date
- 2025-12-25
- Public Version Status
- Update
- Public Device Record Key
- e59f4ea3-0588-4fa2-81b4-2bf6830ddd08
Device Description
HYDRAULIC SURGICAL STOOL
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
- 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 |
|---|---|---|---|---|
| FZM | Stool, Operating-Room | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32307 | Operating room stool, manually-adjusted | A manually-operated seat intended to be occupied by a surgeon or operating room (OR) staff [e.g., surgical nurses, surgical assistants, anaesthetists] during surgical procedures as an alternative to standing. It may provide the occupier with support for the back or arms. It is typically designed with at least one manually-operated ergonomic adjustment (e.g., height and position adjustments), which is typically adjusted by a hand or foot lever, and may features wheels (castors) and breaks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M368744T2SBCSW1 | HIBCC |
Customer Contacts
- Phone
- 7703684700
- [email protected]