FDA UDI
In Commercial Distribution
🇺🇸 United States
Carl
DI: 07350136560200
·
Model: Rn
·
Rini Ergoteknik AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Carl
- Primary DI
- 07350136560200
- Version / Model
- Rn
- Catalog Number
- 120-00133/-00102 -nn
- Company Name
- Rini Ergoteknik AB
- Labeler DUNS
- 354971327
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-08
- Public Version
- 1
- Public Version Date
- 2023-08-16
- Public Version Status
- New
- Public Device Record Key
- 3a9909fc-bd4d-42d7-b36c-8727fcd0da89
Device Description
Surgeon chairs electrical, the “Carl” series are ergonomically designed and are available with various special armrests. The chairs have extensive possibilities for adjusting the backrest and seat and are also easy to raise and lower electrically with the feet.
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 | 07350136560200 | GS1 |