FDA UDI
In Commercial Distribution
🇺🇸 United States
BVI
DI: 00886158037576
·
Model: OME6001U
·
Beaver-Visitec International, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BVI
- Primary DI
- 00886158037576
- Version / Model
- OME6001U
- Catalog Number
- OME6001
- Company Name
- Beaver-Visitec International, Inc.
- Labeler DUNS
- 001406024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-22
- Public Version
- 1
- Public Version Date
- 2025-07-30
- Public Version Status
- New
- Public Device Record Key
- a1f3c533-d8e9-4eb8-bcab-e231ca480b5b
Device Description
Leos laser and endoscopy console
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 |
|---|---|---|---|---|
| HQP | Unit, cautery, thermal, battery-powered | Ophthalmic | 886.4115 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62323 | Endoscopic-imaging ophthalmic solid-state laser system | A mains electricity (AC-powered) device assembly with an integral endoscope video camera and in which input energy from a diode laser is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to treat retinal and other eye disorders, such as glaucoma, during endoscopic cyclophotocoagulation (ECP) procedures. It includes a light source, controls/foot-switch, and is typically connected via a flexible fibreoptic cable to an appropriate hand-held endoscope with laser beam guide introduced into the eye for imaging and laser treatment. It does not include femtosecond pulsing technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00886158037576 | GS1 |
Customer Contacts
- Phone
- +1(866)906-8080
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place.