FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MARCO
DI: 06909071671079
·
Model: MARCO TILT CHAIR
·
TAKAGI SEIKO CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MARCO
- Primary DI
- 06909071671079
- Version / Model
- MARCO TILT CHAIR
- Company Name
- TAKAGI SEIKO CO.,LTD.
- Labeler DUNS
- 690907167
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 3
- Public Version Date
- 2018-10-24
- Public Version Status
- Update
- Public Device Record Key
- bfcba254-93bd-4e00-9ebd-6e88085c14ff
- Distribution End Date
- 2018-10-24
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 |
|---|---|---|---|---|
| HME | Chair, Ophthalmic, Ac-Powered | Ophthalmic | 886.1140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15723 | Ophthalmic chair, line-powered | A mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06909071671079 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius