FDA UDI
In Commercial Distribution
🇺🇸 United States
Endo Optiks®
DI: 30886158016237
·
Model: VPH230A
·
Beaver-Visitec International, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Endo Optiks®
- Primary DI
- 30886158016237
- Version / Model
- VPH230A
- Company Name
- Beaver-Visitec International, Inc.
- Labeler DUNS
- 001406024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 5
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 9fb74e94-bead-4a23-90ad-aaf8fccb9e59
Device Description
23 Gauge Laser Probe
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| HQP | Unit, cautery, thermal, battery-powered | Ophthalmic | 886.4115 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44932 | Rigid optical ophthalmic endoscope | An endoscope with a rigid inserted portion intended for the observation and treatment of the eyeball and related structures. It is inserted into the eye during procedures such as endoscopic vitreoretinal surgery and glaucoma/cataract surgery. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Some endoscopes have a working channel to convey an instrument for procedures. It is typically used for observation of the retina, pars plana, posterior part of the iris, or angle of iris (angulus iridocornealis). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30886158016237 | GS1 |
Customer Contacts
- Phone
- +1(866)906-8080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K910532 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place.