FDA UDI
In Commercial Distribution
🇺🇸 United States
VorOtek L Scope
DI: 09348227000108
·
Model: VSLH-2.5 M
·
VOROTEK PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VorOtek L Scope
- Primary DI
- 09348227000108
- Version / Model
- VSLH-2.5 M
- Catalog Number
- VSLH-2.5 M
- Company Name
- VOROTEK PTY LTD
- Labeler DUNS
- 744332997
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-09
- Public Version
- 1
- Public Version Date
- 2023-08-17
- Public Version Status
- New
- Public Device Record Key
- 545e57a3-67a5-45d1-bb85-49f25bad58c6
Device Description
VorOtek L Scope - HeadBand 2.5X Magnification Loupes @ 42cm working distance with Fully Integrated Surgical Quality Dimmable LED Illumination. Adjustable IPD. Includes Power Pack, Charger & Carry Case.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| HJH | Loupe, Binocular, Low Power | Ophthalmic | 886.5120 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32692 | Surgical binoculars, reusable | A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09348227000108 | GS1 |