FDA UDI
In Commercial Distribution
🇺🇸 United States
MARCO
DI: 04560323648908
·
Model: MARCO TRIAL LENS FRAME
·
TAKAGI SEIKO CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MARCO
- Primary DI
- 04560323648908
- Version / Model
- MARCO TRIAL LENS FRAME
- Company Name
- TAKAGI SEIKO CO.,LTD.
- Labeler DUNS
- 690907167
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-25
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e9bd3fd3-c4fa-4af6-b15e-8dc2d01c7f94
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 |
|---|---|---|---|---|
| HPA | Frame, Trial, Ophthalmic | Ophthalmic | 886.1415 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36453 | Electrical logic circuit meter | An instrument intended to be used to measure/log the signal path or course from logic circuits. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04560323648908 | GS1 |