FDA UDI
In Commercial Distribution
🇺🇸 United States
iStand
DI: 00858848006285
·
Model: iStand
·
OPTOVUE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- iStand
- Primary DI
- 00858848006285
- Version / Model
- iStand
- Catalog Number
- 700-48491-001
- Company Name
- OPTOVUE, INC.
- Labeler DUNS
- 196500461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-03
- Public Version
- 4
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- afd5eb1d-8eca-4e65-b83c-b40075d99661
Device Description
iStand 2
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
- No
- 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 |
|---|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | Ophthalmic | 886.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 39659 | Static ophthalmic equipment stand, electrically-adjusted | An electrically-powered device designed as a column or post, usually with a small flat surface top, used to provide support and position control for ophthalmic devices commonly used during an ophthalmic examination/treatment (e.g., a slit lamp, keratometer, refractometer). It typically has a powered height adjustment function enabling the clinician to align (raise/lower) the ophthalmic instruments to the eye level of the patient. It is typically stationary and may have drawers, shelves, and built-in outlets to supply low-voltage electricity to the instruments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858848006285 | GS1 |
Customer Contacts
- Phone
- 866-941-9240
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103266 | 000 |