FDA UDI
In Commercial Distribution
🇺🇸 United States
Lacrimal Instruments
DI: 00845819005156
·
Model: 6630
·
OASIS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lacrimal Instruments
- Primary DI
- 00845819005156
- Version / Model
- 6630
- Company Name
- OASIS MEDICAL, INC.
- Labeler DUNS
- 194121018
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-30
- Public Version
- 1
- Public Version Date
- 2023-07-10
- Public Version Status
- New
- Public Device Record Key
- 2106678b-c3ed-4671-ac6f-982885867ce1
Device Description
SOFT PLUG® Punctal Plug Gauge Set, 0.5mm/0.6mm and 0.7mm/0.8mm
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNW | Dilator, Lachrymal | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35010 | Lacrimal dilator, reusable | A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845819005156 | GS1 |
Customer Contacts
- Phone
- 9093055400
- [email protected]