FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgical Table
DI: 05907642694619
·
Model: SC-1
·
MDT SP Z O O
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Surgical Table
- Primary DI
- 05907642694619
- Version / Model
- SC-1
- Company Name
- MDT SP Z O O
- Labeler DUNS
- 366126408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-16
- Public Version
- 1
- Public Version Date
- 2025-07-24
- Public Version Status
- New
- Public Device Record Key
- 259604bb-8937-4923-8150-ac21c911c9b7
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 |
|---|---|---|---|---|
| HME | Chair, Ophthalmic, Ac-Powered | Ophthalmic | 886.1140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43383 | Ophthalmic operating table, electromechanical | An electrically-powered motorized table designed to support a patient during ophthalmic surgical procedures. It is adjustable to accommodate various positions (e.g., height, tilt). It is particularly intended to provide support for and stabilization of the head of the patient (typically includes a headrest) and to help provide optimal access for the surgeon(s) during the intervention (e.g., by having a small-width table top and therefore a shorter stretch distance for the surgeon). It may be freestanding or connected to another device or system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05907642694619 | GS1 |