FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OMNI PLUS
DI: 00858027006358
·
Model: 1-104
·
Sight Sciences, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OMNI PLUS
- Primary DI
- 00858027006358
- Version / Model
- 1-104
- Company Name
- Sight Sciences, Inc.
- Labeler DUNS
- 962750381
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-30
- Public Version
- 4
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 69eab465-93c5-4362-9aed-01cded0dc44a
- Distribution End Date
- 2023-10-11
Device Description
OMNI PLUS Surgical System
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | General Hospital | 880.5725 | 2 |
| HMZ | Trabeculotome | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47610 | Ophthalmic needle, single-use | A slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device. | No | Active |
| 62437 | Trabeculotome, single-use | A hand-held manual ophthalmic surgical instrument intended to be used to perform a trabeculotomy, via transluminal access through Schlemm's canal (sinus venosus sclerae) and piercing of the trabecular meshwork, to reduce intraocular pressure (IOP) for the prevention/treatment of glaucoma. It is made of metal and plastic materials, and is in the form of a handle with a thin, flexible, extendable tip at the distal end designed to be progressively inserted into the eye through a corneal incision. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858027006358 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201953 | 000 |