FDA UDI
In Commercial Distribution
🇺🇸 United States
Lidstick
DI: 04049584032454
·
Model: 77500
·
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Lidstick
- Primary DI
- 04049584032454
- Version / Model
- 77500
- Company Name
- OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317138956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-16
- Public Version
- 1
- Public Version Date
- 2023-06-26
- Public Version Status
- New
- Public Device Record Key
- cd325796-85e4-4dc0-8e5b-02130cc5a162
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
- Yes
- 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 |
|---|---|---|---|---|
| HNI | Retractor, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62775 | Meibomian gland manual expressor/evaluator | A non-powered, hand-held manual ophthalmic instrument intended to be used to apply pressure to the lower eyelid to facilitate natural release and/or expression of meibomian gland secretions (meibum) for diagnostic evaluation during a routine eye examination and/or to treat dry eye syndrome. It is a small tool with a handle and a distal end of various configurations (e.g., shaft, paddle, roller, tweezers-like) designed to be gently pressed against the outer skin of the lower eyelid or to gently squeeze the lower eyelid. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049584032454 | GS1 | ||||
| Package | 04049584032959 | GS1 | Individual roll | 100 | In Commercial Distribution | |
| Package | 04049584032966 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 04049584032973 | GS1 | Shipper | 16 | In Commercial Distribution |