FDA UDI
In Commercial Distribution
🇺🇸 United States
Carl Mechanical
DI: 07350136560101
·
Model: Spring/Swing
·
Rini Ergoteknik AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Carl Mechanical
- Primary DI
- 07350136560101
- Version / Model
- Spring/Swing
- Catalog Number
- 120-0010n-0n
- Company Name
- Rini Ergoteknik AB
- Labeler DUNS
- 354971327
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-18
- Public Version
- 1
- Public Version Date
- 2023-08-28
- Public Version Status
- New
- Public Device Record Key
- d7ceab3e-a78d-428a-9845-e341875cd9db
Device Description
Surgeon chair with mechanical height adjustment by an ergonomically designed foot control under the chair. High level of comfort for the surgeon within Eye-, ENT-, Neuro, Plastic-, Dental-, Robot-, and similar types of microsurgery. Can be outfitted with different armrests to match different needs, all easy to use with intuitive settings.
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 |
|---|---|---|---|---|
| HMD | Chair, Ophthalmic, Manual | Ophthalmic | 886.1140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32307 | Operating room stool | A seat, usually padded and height-adjustable, intended to be occupied by operating room (OR) staff during surgical procedures as an alternative to standing; it does not include support for the back or arms. It is intended to be used in operating theatres or clean-rooms and is therefore constructed so that it is easy to clean to help minimize risk of contamination. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350136560101 | GS1 |