FDA UDI
In Commercial Distribution
🇺🇸 United States
FORM FIT® Hydrogel Canalicular Plug
DI: 00845819000274
·
Model: 6303, 6303-T, B-6303
·
OASIS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- FORM FIT® Hydrogel Canalicular Plug
- Primary DI
- 00845819000274
- Version / Model
- 6303, 6303-T, B-6303
- 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
- b286fdb4-feb5-494c-b549-b24547fbe30b
Device Description
Form Fit® Hydrogel Canalicular Plug in Squeeze Inserter
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
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZU | Plug, Punctum | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36237 | Lacrimal punctum plug | A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10845819000271 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 00845819000274 | GS1 | ||||
| Package | 20845819000278 | GS1 | Carton | 2 | In Commercial Distribution | |
| Package | 30845819000275 | GS1 | Plastic Bag | 100 | In Commercial Distribution |